15
CORPORATE EUROPE OBSERVATORY Exposing the power of corporate lobbying in the EU THE POWER OF LOBBIES ECONOMY & FINANCE ENVIRONMENT FOOD AND AGRICULTURE INTERNATIONAL TRADE Biotech lobby’s push for new GMOs to escape regulation 'New Breeding Techniques' the next step in corporate control over our food? FEBRUARY 2ND 2016 FOOD AND AGRICULTURE The biotech industry is staging an audacious bid to have a whole new generation of genetic engineering techniques excluded from European regulations. The pending decision of the European Commission on the regulation of these so-called 'new GMOs' represents a climax point in the ongoing below-the-radar attack by industry on GM laws. 1. Introduction The EU's GM regulations have long been a thorn in the biotech industry's side. For their lobbyists, the Commission decision presents a unique opportunity to twist the interpretation of these rules – including the very definition of a GMO – so as to exclude the new genetic engineering techniques from their scope. This goes alongside ongoing industry attacks on the application of the precautionary principle – the basis of EU GM regulations – to novel food production techniques. New genetic engineering techniques, which have emerged since Europe’s GMO law was introduced in 2001, are currently being applied by developers to food crops, trees, farm animals and insects. If the industry lobby campaign is successful, new GM organisms and foods – produced by techniques including oligonucleotide-directed mutagenesis (ODM), agroinfiltration and zinc finger nuclease technology (ZFN) - could enter the environment and the food chain untested, untraceable and unlabeled. Dozens of patents have already been filed in this field by the big agrochemical corporations like Bayer, BASF, Dow Agrosciences and Monsanto. Due to widespread consumer rejection of GMOs, invisibility is vital for the commercial success of any new genetically engineered product in Europe. Their unregulated mass release could however have far-reaching consequences for the environment, food safety

FOROEUROPA - Biotech lobby’s push for new GMOs to escape … · 2016-02-04 · With respect to cisgenesis and intragenesis, EFSA concluded that while intragenic plants would generate

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Page 1: FOROEUROPA - Biotech lobby’s push for new GMOs to escape … · 2016-02-04 · With respect to cisgenesis and intragenesis, EFSA concluded that while intragenic plants would generate

CORPORATE EUROPE OBSERVATORYExposing the power of corporate lobbying in the EU

THE POWER OF LOBBIES ECONOMY amp FINANCE ENVIRONMENT FOOD AND AGRICULTURE INTERNATIONAL TRADE

Biotech lobbyrsquos push for new GMOs to escape regulation

New Breeding Techniques the next step in corporate control over our foodFEBRUARY 2ND 2016 FOOD AND AGRICULTURE

The biotech industry is staging an audacious bid to have a whole new generation of genetic engineering techniques

excluded from European regulations The pending decision of the European Commission on the regulation of these

so-called new GMOs represents a climax point in the ongoing below-the-radar attack by industry on GM laws

1 Introduction

The EUs GM regulations have long been a thorn in the biotech industrys side For their lobbyists the Commission decision

presents a unique opportunity to twist the interpretation of these rules ndash including the very definition of a GMO ndash so as to exclude

the new genetic engineering techniques from their scope This goes alongside ongoing industry attacks on the application of the

precautionary principle ndash the basis of EU GM regulations ndash to novel food production techniques

New genetic engineering techniques which have emerged since Europersquos GMO law was introduced in 2001 are currently being

applied by developers to food crops trees farm animals and insects If the industry lobby campaign is successful new GM

organisms and foods ndash produced by techniques including oligonucleotide-directed mutagenesis (ODM) agroinfiltration and zinc

finger nuclease technology (ZFN) - could enter the environment and the food chain untested untraceable and unlabeled Dozens of

patents have already been filed in this field by the big agrochemical corporations like Bayer BASF Dow Agrosciences and

Monsanto

Due to widespread consumer rejection of GMOs invisibility is vital for the commercial success of any new genetically engineered

product in Europe Their unregulated mass release could however have far-reaching consequences for the environment food safety

What are the new GM techniques

The list of new GM techniques currently being considered by the

Commission includes Oligonucleotide-Directed Mutagenesis

(ODM) Zinc Finger Nuclease technology (ZFN) comprising ZFN-1

ZFN-2 and ZFN-3 Cisgenesis and Intragenesis Grafting

Agroinfiltration RNA-dependent DNA methylation (RdDM) and

Reverse Breeding Most of these techniques are also called gene

editing editing techniques instead of introducing genetic traits

from another organism the genome can be directly rewritten in

the cells

Indeed companies appear to be deliberately investing in

techniques designed to circumvent the EUs GMO regulations As

an expert for the US Consumer Union has noted ldquoAll these new

technologies are ways to weasel around a very narrow definition of

transgenic I would consider that misleading to the publicrdquo An

industry lobby document sent to EU decision makers in 2013 could

not be clearer about the industrys motivation to develop new GM

techniques they were developed ldquoas a response to the de facto

moratorium on GMOs that currently exists in Europerdquo These

investments and the many related patent applications now

demand a financial return

EFSA opinions on three techniques

and consumer choice Therefore calls from farmers and environmental groups to regulate the new GM are increasing The

techniques in question each bring their own set of risks and uncertainties Technical reports and legal analyses by government

bodies and NGOs have concluded that GM 20 should not escape the EU GM regulations Whilst some risks are similar to those

associated with GM 10 there are also serious additional concerns

To further its cause industry has set up a dedicated EU-level lobbying vehicle ndash the New Breeding Techniques Platform ndash with the

mission of having as many of the new GM t echniques as possible excluded from EU GM regulations This platform is run by

Schuttelaar amp Partners a Dutch lobby and PR firm with a shady reputation for pro-GM lobbying At the same time individual

companies have been pressing various European governments to clarify the legal status of the new genetic engineering techniques

while announcing plans to field trial them in those countries Furthermore certain governments have been actively advocating the

deregulation of new GM techniques at the EU level

The ongoing negotiations around the Transatlantic Trade and Investment Partnership (TTIP) are an additional source of political

pressure on European decision makers In this context industry lobby groups have presented the regulation of new GM techniques

as a trade concern to both US and EU officials claiming that the innovative nature and competitiveness of the European plant

breeding (read biotech) sector is at stake

After contemplating this question for eight years the Commission finally plans to publish a draft decision in February 2016 This

briefing based on documents released by the European Commission following freedom of information requests illuminates the

efforts made over the past three years by the industry lobby to have the new GM techniques deregulated In addition a first case

study highlights the Dutch lobby campaign for the deregulation of cisgenesis and a second one looks at Canadian company Cibuss

push for the deregulation of its ODM oilseed rape

2 A lengthy process

The European Commission turned its attention to the new GM techniques eight years ago setting up a New Techniques Working

Group (NTWG) in October 2007 to assess whether the GM techniques listed above give rise to products falling within the scope of

the GMO legislation However its final report showed that the working group was divided on the regulatory status of some of the

techniques therefore leaving the Commission with no clear plan of action

In parallel to the analysis carried out by this Working Group the

Commission requested opinions from the European Food Safety

Agency (EFSA) about the risks posed by cisgenesis intragenesis

and Zinc Finger Nuclease 3 and whether existing risk assessment

methods were adequate for evaluating them

In 2012 the Commission reported that it was working with

member states to find the best way forward in clarifying the

regulatory status of the new techniques In a presentation to

the European Seed Association the Commission claimed to be

looking not only at the legal aspects but also at ldquosafety

considerations the approach in third countries the chances and

risks involved and the view of European plant breedersrdquo

Just months later at a meeting with the industry-led NBT

Platform the Commission had changed course It was later

clarified that due to ldquothe absence of consensus amongst the main

political EU actors reflecting the public hostility to GMOsrdquo the

Commission had opted for a legal guidance document

interpreting Directive 200118 rather than for new legislation

This means that the European Parliament plays no formal role

and that member states are expected to follow the Commissions

recommendations In the case of disagreement the European

Court of Justice has the final say

The Commission has time and time again postponed the

1

2

3

4

5

6

7

8

9 10

12

13

14

With respect to cisgenesis and intragenesis EFSA concluded that

while intragenic plants would generate similar risks to transgenic

ones cisgenic plants could be compared to conventionally bred

plants However the agency clarified that ldquoall of these breeding

methods can produce variable frequencies and severities of

unintended effects The frequency of unintended changes may

differ between breeding techniques and their occurrence cannot be

predicted and needs to be assessed case by caserdquo Furthermore

EFSA opined that ZFN-3 requires in principle the same risk

assessment that is currently applied to GMOs but that on a case-

by-case basis ldquolesser amounts of data may be neededrdquo for plants

developed using this technique

Schuttelaar amp Partners no novice to below-the-radar lobby campaigns for biotech clients

In 1995 the firm was hired by Monsanto to secure a smooth

introduction for the first imports of a GM crop ndash Monsantos

herbicide-tolerant Roundup Ready soy ndash to Europe Schuttelaar

amp Partners was set up by Marcel Schuttelaar a former campaigner

for Friends of the Earth Netherlands Familiar with Monsantos

adversaries as an insider and an outsider he was the ideal man for

the job The strategy chosen was to lsquolet sleeping dogs lie carefully

injecting tranquillising messages into the right ears in order to

avoid a sudden outcry from media and consumer organisations

The lobby firm ndash not hindered by a lack of evidence - stressed the

benefits of Roundup Ready soy such as reduced pesticide use (a

claim that has proven to be untrue)

deadline for delivering the legal guidance document In response

to the many queries from industry and member states on its

progress the standard response has been that assessing the new

techniques in the light of Directive 200118 ldquo is complex and

requires a thorough technical and legal analysisrdquo

As the Commission indicated the member states were divided

Certain EU governments including the UK the Netherlands and

Germany pressured the Commission to deregulate one or more

of the techniques The Netherlands for instance has invested

considerable public research funding in promoting the cisgenic

GMOs developed by Wageningen University and the

Commission has been pressured by Dutch Ministries the

Permanent Representation in Brussels the national parliament

and Dutch MEPs (See case study Of apples and potatoes the Dutch lobby for the deregulation of cisgenesis)

Not surprisingly corporations have been itching to get started on field trials of the new GM crops Between 2012 and 2014 BASF

and the Canadian company Cibus (among others) approached several member states including the UK Sweden and Finland to

ascertain the regulatory status of one of the techniques ndash Oligonucleotide-Directed Mutagenesis (ODM) ndash and to obtain clearance

to field trial ODM herbicide-tolerant oilseed rape without having to undergo the regulatory risk assessment required of GMOs

(See case study Canadian company railroads EU decision making on new GM)

This resulted in the Finnish government complaining to the Commission about the lack of clarity of direction on ODM leaving

the national competent authorities ldquoin a legally challenging positionrdquo since they were obliged to respond to the companies

Helsinki gave the Commission an April 2014 deadline to respond but again the Commission told them to be patient

3 New Breeding Techniques Platform corporations unite to deregulate GMOs

The trail of Freedom of Information requests over the past three years to the European Commission illuminates industrys efforts

to have new genetic engineering techniques escape regulation These efforts are coordinated by the New Breeding Techniques

(NBT) Platform whose objective is to have ldquoall NBTs ndash or as many techniques as possible ndash exempt from GM legislationrdquo The

Brussels office of Dutch lobby and public relations firm Schuttelaar amp Partners (their motto ldquoscience-based consultancy with

senserdquo) was hired to chair the NBT Platform and coordinate its lobby activities

This was perhaps not a surprising choice as company materials show that Schuttelaar amp Partnersrsquo recent clientegravele includes various

biotech industry actors whose interests are served by the NBT Platform (for example Syngenta Bayer CropScience Dow

AgroSciences biotech lobby association EuropaBio and Inova Fruit) Also the firm has not shunned highly damaging industry

campaigns in the past its first triumph was tricking decision makers into allowing Monsantos herbicide-tolerant soy to flood the

European market (See Box Schuttelaar amp Partners no novice to below-the-radar lobby campaigns for biotech clients)

Any self-respecting PR firm designing a lobbying campaign will

start off by rebranding its clients product and developing a new

lexicon to pitch it to decision makers

The NBT Platform with its very name has rebranded the new

GM techniques as new breeding techniques to make them

sound different from genetic engineering Not without success

the European Commission and other regulatory bodies have fully

adopted this term in their communication on the topic Angelika

Hilbeck senior researcher at the Swiss Federal Institute of

Technology says ldquoNew breeding techniques is a misleading

term precisely because the users of these techniques aim to

avoid any breeding They simply allow the maintenance of a

successful market variety and the improvement of an agronomic

problem that primarily arises from monoculture production

methods that promote disease and the prevalence of pests The

11

15

16

17

18

19

20

By subtly expanding the European market Schuttelaar amp Partners

helped pave the way for the further expansion of GM soy

monocultures in South America Ironically 15 years later the firm

was hired by and participated in the Round Table on Responsible

Soy (RTRS) which includes Monsanto in its membership The

RTRS is a voluntary labelling scheme that certifies GM Roundup

Ready soy as responsible although its empty criteria do nothing

to protect local communities or reduce deforestation and pesticide

use

New GM same old pitch

So why do we need a new generation of GM The NBT Platform

and other deregulation advocates echoe the arguments in favour of

introducing GM crops 20 years ago in their pitch for the new GM

techniques They invariably cite some of the key

challenges faced by society today notably ldquorapid world population

growth climate change and increasing scarcity of resources such

as soil and waterrdquo New GM techniques it is said will come to

the rescue by massively improving the precision and speed of the

plant breeding process Important objectives allegedly include pest

resistance and drought tolerance Yet the very first new GM crop in

the pipeline developed by the Canadian company Cibus is another

herbicide-tolerant oilseed rape Herbicide-tolerant GM crops have

waged social and environmental havoc in the countries where they

are mass produced Many GM 20 patent applications are related

to traits such as herbicide-tolerance insecticide production and

changed oil composition - the same as GM 10 Furthermore the

claims about the benefits of GM 10 have been refuted time and

again

products will be sold under the same familiar names except they

are now patented and ndash if industry gets its way - not labelled as

GM The techniques are non-innovative and just like GM 10

are primarily a business modelrdquo

Other labels in the new lexicon such as gene editing or

genome editing are used to emphasise surgical precision and to

suggest absolute technological control of the genetic engineering

process However as Hilbeck points out precision in changing

an organisms genetic makeup is not equivalent to safety if you

do not fully understand what you are changing and the knock-

on impacts ldquoIts like changing letters in words and words in text in a language one does not understand That can be done with

precision and control yet with complete oblivion to the meaningrdquo she says

Another key ingredient is to develop a narrative that tells how indispensable the product will be for the greater good ndash even if you

cant come up with anything new (See box New GM same old pitch)

Schuttelaar amp Partners describes the work of the NBT Platform

as providing decision makers with ldquoindependent science-based

informationrdquo on the techniques and generating awareness about

ldquotheir widespread benefitsrdquo for the European economy But

the NBT Platform is far from independent with the private

sector making up the bulk of its membership and providing most

of the funding The membership fee structure as provided on

the Platforms website lists annual subscription fees of euro7000

for Small and Medium-sized Enterprises (SMEs) euro22500 for

large companies and euro2500 for scientific institutions

However none of this is evident from the EU Transparency

Register entries of the NBT Platform and Schuttelaar amp Partners

In fact the entries of both parties exemplify the often

meaningless incomplete and incorrect information provided by

corporations and lobby firms to this register In this case the

NBT Platforms first listing in the Transparency Register is from

April 2015 at least three years after its foundation The

connection to Schuttelaar amp Partners is not mentioned and

neither the Platform members nor the funding sources are

disclosed (Also see box Transparency register generates

confusing and incorrect data on NBT Platform)

Transparency register generates confusing and incorrect data on NBT Platform

In the EU Transparency Register the NBT Platform claims that its lobby expenses total a mere euro50000-99999 per year This figure is

not very meaningful since every entity can invent its own way to calculate lobby expenses when signing up to the register As the

Platforms overall budget is not disclosed lobby costs might in fact be much larger Furthermore the NBT Platform entry reports only a

05 FTE workload dedicated to the wide range of lobby activities falling under the scope of the register Schuttelaar amp Partners Director

Edwin Hecker is named as chair of the Platform and the number of lobbyists with permanent accreditation to the European Parliament

is registered as zero However in Schuttelaar amp Partners own entry to the EU Transparency Register Hecker is mentioned as one of ten

company employees holding a permanent accreditation pass to the European Parliament

There is more information available on the NBT Platformrsquos own website but this was only launched in July 2015 The site lists the

following members Syngenta KeyGene Inova Fruit SESVanderHave Rijk Zwaan Meiogenix SweTree Technologies Semillas Fitoacute

Enza Zaden Rothamsted Research VIB (Flemish Biotechnology Institute) Fondazione Edmund Mach and the John Innes Centre

Commission documents however indicate that Dow Agrosciences and Bayer CropSciences vegetable seed business Nunhems were

21

22

23 24 25 26

27

28

29

30

31 32

33

34

35

36

also at some point members of the Platform and in any case attended NBT meetings

The NBT Platform does not let an opportunity pass to stress the interests of SMEs and research institutes in its lobby to get new

GM deregulated However taking the EU definition of a SME as a company with fewer than 250 employees only three Platform

members qualify KeyGene Meiogenix and SweTree Technologies Furthermore some of the lsquopublicrsquo research institutes that the

NBT Platform represents have strong financial ties with industry For instance Rothamsted Research (UK) has many joint projects

with agribusiness corporations And no less than one third of the general council membership of the Flemish Biotechnology

Institute (VIB) is made up of industry representatives including Syngenta and Bayer

Indeed it is important to note that both biotech SMEs and (semi-) public research institutes often play the role of technology

suppliers for big multinationals SweTree Technologies for example is engaged in the development of GM trees and claims to have

applied for 75 patents in that field Some of these products have already been licensed to BASF and SweTree Technologies claims to

collaborate with the corporation in several areas

4 Multi-phased lobby campaign against EU GMO regulation

The NBT Platformrsquos website clearly delineates the four phases of its campaign to give the death blow to GMO regulation for new

GM products

Source NBT Platform website

Following the creation of the NBT Platform in the first phase the second phase in the industryrsquos lobby campaign to the European

Commission was characterised by repeated efforts to showcase the new techniques and their claimed benefits as well as the

provision of technical and legal arguments for why they should go unregulated

In the spring of 2012 for example Schuttelaar amp Partners teamed up to chair two meetings presenting new GM techniques to staff

from DG SANCO DG Trade and DG Research and Innovation Dow presented Zinc Finger Nuclease (ZFN) technology Rijk

Zwaan introduced agroinfiltration and reverse breeding BayerNunhems explained cisgenics KeyGene made a pitch for ODM and

VIB put forward grafting on GM root stock Syngenta and Inova Fruit were also present at the meetings

In addition a legal argumentation as to why the EU should not regulate ODM and cisgenics techniques in particular was presented

by Wageningen University plant researcher Henk Schouten who was also wearing his hat as lobbyist for Inova Fruit Inova Fruit

owned by large Dutch and Flemish fruit traders contracted the private arm of Wageningen University to develop cisgenic apple

varieties Both Wageningen University and Inova Fruit clearly have commercial interests in getting cisgenesis deregulated This

shows the involvement of Wageningen University in private interest lobbying despite its public denial of this kind of activity (See

case study Of apples and potatoes the Dutch lobby for the deregulation of cisgenesis)

In May 2013 the NBT Platform presented the Commission with

37 38

39

40

41

42

43

44 45

46

47 48

Trade concerns (1) avoiding disruptions at all costs

In lobbying the Commission DG Trade was not left out In a first

meeting in March 2012 Schuttelaar amp Partners raised their clientsrsquo

concerns about ldquothe legislative uncertaintyrdquo for new GM

techniques and added that in this field ldquothe EU occupies the

second place in the world for patent applications with the UK and

the Netherlands contributing most significantlyrdquo In late May

2012 Schuttelaar amp Partners staged a second larger meeting

attended by DG SANCO DG Trade and ldquoNBT Platform membersrdquo

Dow Agrosciences VIB KeyGene Syngenta Bayer CropScience

Rothamsted Research Rijk Zwaan and Wageningen University

Their message did not fall upon deaf ears After the first meeting a

DG Trade official concluded that his DG would ldquohave to ensure

that any measuresolution proposed will not result in trade

disruptionsrdquo And furthermore he reported ldquoI was reassured by my

SANCO counterparts that the trade angle will be taken into

account when deciding on the Commissionrsquos line to takerdquo

The European Seed Association announced to DG SANCO that it

wanted new GM techniques deregulated and specifically attacked

the EU traceability and labelling requirements for their ldquopotential

to hamper free traderdquo

its piegravece de reacutesistance the industryrsquos own lsquolegal interpretationrsquo of

the regulatory status of new GM techniques This was based on

a sort of questionnaire consisting of seven main questions (and

many subquestions) that it is explained must all be answered in

the affirmative in order for a product to be regulated as a GMO

This methodology was carefully designed to ensure the desired

outcome that all of the new GM techniques in question should

be unregulated and by extension untested and unlabelled

Source NBT Platform website

Question 3 and 4 aim to twist the definition of a GMO in EU Directive 200118 which is ldquoan organism with the exception of

human beings in which the genetic material has been altered in a way that does not occur naturally by mating andor natural

recombinationrdquo Using industrys methodology most of the new techniques would escape regulation as they can provide a negative

answer to one of these two questions The Platform analysis also argues that some of the new GM techniques are simply a

variation of mutagenesis (a technique that had long been in use when Directive 200118 was developed and that was explicitly

excluded from its scope) Furthermore the industry approach aims to undermine the process-based nature of the Directive as

described earlier

The arguments put forward by the NBT Platform are at the core of industrys rationale for the deregulation of new GM These

points or variations on them can also be found in lobby documents produced by the European Seed Association (ESA) the

European Plant Science Organisation (EPSO) the pesticide lobby group Croplife International and the Flemish biotech research

institute VIB

The pro-deregulation interpretation of the scope of Europersquos GM laws has been met with wide-ranging criticism Counter-

arguments have been provided by German federal agencies (for example the opinion by Professor Tade Matthias Spranger for BfN

the German Federal Agency of Nature Conservation) a legal analysis by Professor Ludwig Kraumlmer as commissioned by German civil

society and assessments by Greenpeace farming and other environmental groups Similarly industryrsquos attempt to have new GM

49

50

51

52

53

54

55

declared safe by design and therefore exempt from regulatory risk assessment has been countered by the Austrian Environmental

Agency and various non-governmental organisations

The legal case that new GM techniques should be covered by the current regulations is in fact crystal clear

The central purpose of Directive 200118 on the deliberate release of GMOs is to protect human health and the environment from

the release of genetically modified organisms The Directive clearly provides for the advent of new GM techniques which rely upon

in vitro methods to directly modify genomes These are the very type of techniques that EU law covers with its process-based

approach (where the technique used decides if the regulations apply) That process-based regulation and the precautionary

approach that lies at the heart of the directive are justified because of the unintended and unexpected effects of both GM 10 and

GM 20 techniques Techniques that have been developed since 2001 (or that didnt have any commercial application prior to 2001)

cannot be regarded as industry argues the same as traditional mutagenesis techniques that were exempted on the grounds of a

claimed history of safe use when the EU regulations were introduced

The key arguments from industry and counter-arguments are summarised in the following table

Table Key industry arguments for the deregulation of new GM techniques

Industry argument Response

1 ldquoNew GM is just l ike traditional plant1 ldquoNew GM is just l ike traditional plant

breedingrdquobreedingrdquo

Products from new GM are just like traditionally bred

plants since ldquono foreign DNA is usedrdquo Industry seeks to

reframe the legal interpretation of a GMO in this way

because many of the new techniques do not necessarily

use DNA from another species or use genetic material

other than DNA

In EU law a GMO does not need to contain foreign DNA to qualifyIn EU law a GMO does not need to contain foreign DNA to qualify

as a GMOas a GMO

The Directive refers to ldquoan organism hellipin which genetic material has been

altered in a way that does not occur naturally by mating andor natural

recombinationrdquo The new techniques directly modify an organismrsquos genetic

material without involving mating and are therefore genetic engineering In

addition the Directive also qualifies the introduction of other types of genetic

material than DNA as GM

2 ldquoJust because a GM technique is used does2 ldquoJust because a GM technique is used does

not mean that the product is legally a GMOrdquonot mean that the product is legally a GMOrdquo

If there is no GM material present in the final product

it should not be treated as a GMO This is an attack on

the process-based (technique-based) nature of the

Directive and would mean that products of several

methods that do involve GM would be exempt

The EU has The EU has recognisedrecognised that the GM that the GM technique usedtechnique used to to changechange an an

organisms organisms does does mattermatter

Itrsquos the genetic engineering process that can lead to unintentional alterations

of the genetic material giving rise to concerns regarding food and

environmental safety These concerns remain even if the genetic engineering

agent is subsequently removed

3 ldquoGene editing techniques are a form of3 ldquoGene editing techniques are a form of

mutagenesis rdquomutagenesis rdquo

Mutagenesis is excluded from the scope of the

Directive as it was assumed to have a history of safe

use

New gene editing techniques are different and have no histor y ofNew gene editing techniques are different and have no histor y of

safe usesafe use

They are different from the mutagenesis techniques (chemical and radiation)

referred to in the Directive

4 ldquoNew GM is safe by designrdquo4 ldquoNew GM is safe by designrdquo

The claim is that the genetic interventions are precise

and targeted and therefore safe This is reflected by the

terms used gene or genome editing

New GM techniques can have multiple unintended and unexpectedNew GM techniques can have multiple unintended and unexpected

results results

New GM methods pose very similar types of risks as GM 10 and should be

regulated at minimum in the same way as existing GMOs in order to protect

the environment and public health Precision in changing the genetic makeup

of an organism does not equate safety if you do not fully understand the

impacts

5 ldquoDetection is impossiblerdquo5 ldquoDetection is impossiblerdquo

Industry claims that detection methods will not be able

Detection methods are evolving as are genetic engineeringDetection methods are evolving as are genetic engineering

techniques techniques

56 57

Trade concerns (2) TTIP kicks in

Another line of argument pursued by the NBT Platform is the

comparison of how new GM techniques are regulated ndash or not ndash in

other parts of the world cumulating in the suggestion that a

stronger level of regulation in the EU will create trade barriers

In the context of TTIP the way the US deals with the new

techniques is of particular interest For example US-based

multinational Dow informed DG SANCO in 2013 of the decision by

the US Department of Agriculture (USDA) to not regulate Dows

ZFN-1 maize The Commission later reflected however that the

US Food and Drug Administration (FDA) ldquoremains rather vaguerdquo on

the issue It should be noted that the US hardly regulates GMOs

as such There are no formal data requirements when it comes to

safety testing and biotech companies voluntarily provide whatever

information they please

Emails released by the Commission provide evidence that the (de-

)regulation of new GM techniques was indeed discussed in a March

2014 TTIP-related meeting in Washington Despite repeated claims

at the time by the Commission that ldquoGM is not on the tablerdquo US

and EU authorities sat together with seed industry lobby groups

from both sides of the Atlantic (including the European Seed

Association)

to tell the difference between a new GM and a

traditionally-bred product

While distinguishing some new GM products from non-GM products may

currently be difficult this is very likely to change in the future

6 ldquoApplication of the precautionar y principle6 ldquoApplication of the precautionar y principle

should be reconsideredrdquoshould be reconsideredrdquo

Industry claims that since there is less uncertainty

related to new gene editing techniques than with

mutagenesis using radiation or chemical mutagens and

since the precautionary principle is about uncertainty it

should not be applied to new GM techniques

Precautionar y principle should be respectedPrecautionar y principle should be respected

The precautionary principle and the process-orientated approach to risk

assessment as established under EU law can only be implemented if the new

methods are covered by the Directive

5 Last phase lobbying

The third phase of the industry campaign indicated in the graph by lsquoPoliticsPublic Affairsrsquo (read Lobby) kicked in with a so-

called multi-stakeholder meeting held on 25 June 2014 lsquoThe future of plant breeding techniques in the European Unionrsquo was a

co-production of the NBT Platform and the industry-driven European Technology Platform Plants for the Future However the

NBT Platform cast a narrow net when inviting lsquostakeholdersrsquo on its list were the Member States Competent Authorities the

Commission and companies and their lobby associations (eg the European Seed Association farming lobby Copa-Cogeca and so

forth) Absent were environmental and consumer NGOs sustainable farming organisations and the like

The industry campaign escalated during this phase with dire predictions of economic collapse and job losses following the

eventual regulation of new GM According to the NBT Platform multi-stakeholder meeting report for example industrial farming

group Copa-Cogeca said that ldquooverly strictrdquo regulation would ldquoincrease unfair competitionrdquo for farmers In turn the European Plant

Science Organisation (EPSO) insisted that the current legal uncertainty was causing ldquointelligence leakagerdquo and destroying jobs

while another participant went as far as to warn that this ambiguity would lead to the ldquocomplete extinctionrdquo of a large part of the

plant breeding sector in Europe

By the start of 2015 the Commission appeared close to reaching

a decision on new GM techniques and things were starting to

heat up

In the spring the German Government decided to take matters

into its own hands It determined that Cibus ODM oilseed rape

did not qualify as a GMO so that field trialling could proceed

with no regulation or monitoring In response the Commission

quickly sent letters to Germany and all EU member states asking

them to ldquoawait as much as possible the outcome of the

Commission legal interpretation before authorising a deliberate

release of organisms obtained with new plant breeding

techniquesrdquo since ldquothe deliberate release of products which are

subject to the rules of the EU GMO legislation without

appropriate prior authorisation is illegalrdquo (See case study

Canadian company railroads EU decision making on new GM)

But Cibus also informed the Commission that as its product was

already being grown in the US ldquothe harvested material is used

like any other crop and likely entering the international

commodity chainrdquo According to the company the possibility of

this unauthorised GM oilseed rape being imported into the EU

could therefore not be excluded

Following the May 2014 elections a new Commissioner in charge

of DG SANTE (previously called SANCO) was installed the

Lithuanian Vytenis Andriukaitis The NBT Platform set the

58

59

60

61

62

63

64

65

66

necessary liaison efforts into motion and set up a meeting that took place in July 2015 The Platform also shifted focus to liaise

and gather information from EU member states and sought a meeting with the Commission (DGs SANTE AGRI and Trade) to

report back on these contacts

Furthermore at two occasions in 2015 GM developers got assistance from certain member states that have also been peddling a

pro-deregulation agenda with Brussels In May 2015 a lsquonon-paperrsquo authored by Germany the UK Ireland and Spain argued for the

deregulation of the ODM technique in particular using the same arguments as put forth by industry to argue that ldquoODM is a

variation of mutagenesisrdquo

In September the German food safety agency BVL in a joint exercise with its UK and Irish colleagues sent an interpretation of the

definition of a GMO in Directive 200118 to the Commission This document precisely echoes the industry discourse that a

product should only be regulated under EU GMO laws if it is produced by a GM process and if the result is a product that could

not have been achieved in a lsquonaturalrsquo way

Flemish biotechnology institute (VIB) and EASAC join the chorus

In this last phase corporate-backed research institutes like the Flemish VIB also stepped up their efforts in order to defend their

commercial interests On 5 June 2015 the VIB met with the Commission to discuss a number of new techniques Although the list

has not been disclosed following freedom of information requests according to the VIB ldquo the examples given represent concrete

business opportunities and vulnerable information from the viewpoint of competitionrdquo It appears likely from the Commission response

and a related email exchange on the topic that the VIB is eyeing cisgenesis and certain gene editing techniques VIB has an obvious

commercial interest in the deregulation of cisgenesis after having put its money on turning the failed Dutch cisgenic potato into a

Belgian specialty a blight-resistant Bintje a well known potato variety widely used for the countrys famous fries

Moreover in a remarkable statement addressed to the Commission in July 2015 the European Academies Science Advisory Council

(EASAC) also backed industrys views Their political demands dovetail with those of industry GMOs should be allowed to escape

regulation ldquowhen they do not contain foreign DNArdquo that GM products should be regulated only by trait and not technique and that the

use of the precautionary principle in GM regulation should be reconsidered The statement is based on the conclusions of an earlier

EASAC report Planting the Future This report was composed by a working group of experts acting in individual capacity nominated

by member academies of EASAC

Meanwhile in the European Parliament some MEPs unsuccessfully demanded a formal say in the process Others including Jan

Huitema (Liberals) and Anthea McIntyre (Conservatives) authored resolutions that included calls for the deregulation of new GM

techniques On 1 December 2015 a hearing took place in the European Parliament Agriculture Committee Edwin Hecker a NBT

Platform lobbyist and an employee of Schuttelaar amp Partners (although the latter was not disclosed) presented industrys views

again overstating the role of SMEs

Surprisingly only one week later the NBT Platform was deleted from Schuttelaar amp Partners list of clients in the register However

the information in the NBT Platforms entry and on its website remains unchanged (See box Does the NBT Platform still exist)

Does the NBT Platform still exist

Schuttelaar amp Partners made some remarkable changes to their registry entry on 7 December 2015 The NBT Platform has been deleted

as a client from the lobby groups entry This is contradictory as the NBT Platformrsquos entry is unchanged and still lists Mr Hecker as its

chair In line with this change the Commissions legal interpretation of Directive 200118 for the new GM techniques has been deleted

from the list of EU initiatives followed by the company

In addition the companys overall lobby-related expenses have been reduced tenfold from euro100000-500000 down to euro50000-99000

The consultancy now declares just a 08 FTE workload for lobbying activities This is at odds for instance with the fact that ten

employees currently hold lobby passes for the European Parliament

6 The Commissions interpretation Whose interests will prevail

All invested parties are now awaiting the Commissions decision to be presented in March 2016 Will the NBT Platform be

celebrating victory after achieving its Phase 4 Agreement goal Or will concerned governments NGOs and sustainable farming

67

68

69

70 71

72 73

74

75

76

77

78

79

80

organisations be relieved that the new GM technologies will be subject to the existing hard-won regulation

Maybe neither DG SANTE has already publicly stated that ldquosome will be pleased others disappointedrdquo indicating that at least

one perhaps more but not all of the new techniques will escape regulation as a result of the Commission decision If true this

would ndash no matter how many techniques are concerned ndash be a serious attack on food and environmental safety consumer choice

and transparency in the food chain as well as enhancing corporate concentration in the seed sector through patents

As Brussels itself realises the Commission release is probably just the beginning ndash and not the resolution ndash of this contentious

issue In all likelihood it will be the European Court of Justice that ultimately determines the regulatory fate of new GM

techniques The court case brought by environmental and farming organisations against Cibus ODM oilseed rape will therefore be

of great importance

In the meantime neither the biotech industry nor its financiers are likely to have the certainty they have been striving for

Furthermore other actors may still come into play Food distributors may demand direct liability for new GM products to those

who put them on the market And parliaments may insist on the labelling of new GM products like has happened in the

Netherlands The TTIP negotiations on the other hand may become a force against a proper regulation of GM 20 Environmental

and sustainable farming groups will have to remain on high alert

81

- Eckerstorfer M et al Environmental Agency Austria Technical report New plant breeding techniques and risks associated with their application 2014

httpwwwumweltbundesamtatfileadminsitepublikationenREP0477pd

- Kraumlmer L Legal questions concerning new methods for changing the genetic conditions in plants Legal analysis commissioned by Arbeitsgemeinschaft

baumluerliche Landwirtschaft (AbL) Bund fuumlr Umwelt und Naturschutz (BUND) etc September 2015

httpwwwtestbiotechorgsitesdefaultfilesKraemer_Legal20questions

- Spranger TM Legal Analysis of the applicability of Directive 200118EC on genome editing technologies Commissioned by the German Federal Agency

for Nature Conservation October 2015 httpbfndefileadminBfNagrogentechnikDokumenteLegal_analysis_of_g

Steinbrecher Ricarda Genetic Engineering in plants and the ldquoNew Breeding Techniques (NBTs)rdquo December 2015

httpwwweconexusinfopublicationgenetic-engineering-plants-and-new-

Corporate Europe Observatory and Inf OGM TTIP released emails show biotech seeds on the trade talks table 2 July 2015

httpcorporateeuropeorgfood-and-agriculture201507ttip-released-em

The Working Group was made up of two experts nominated from each member state Its final report was completed in 2012 but was never officially

published

See for a description of the techniques and reasons why they should be regulated Steinbrecher Ricarda Genetic Engineering in plants and the ldquoNew

Breeding Techniques (NBTs)rdquo December 2015 httpwwweconexusinfopublicationgenetic-engineering-plants-and-new-

Testbiotech Gene-editing and plants amp animals used in food production some technical socio-economic and legal aspects Backgrounder for Hearing on

ldquoNew Techniques for Plant Breedingrdquo in the EP Agriculture Committee 1 December 2015

httpwwwtestbiotechorgsitesdefaultfilesLegal20and20technical2

Waltz Emily Tiptoeing around Transgenics In Nature Biotechnology volume 30 number 3 March 2012

NBT Platform Fact sheet New Breeding Techniques Seizing the opportunity Version 2013

The Commission prioritised these techniques specifically since they entail ldquothe introduction of exogenous [that is lsquoforeignrsquo] genetic material into the

host which is the case for these techniques as it is for transgenesisrdquo

DG SANCO Steering note for NBT Platform meeting ldquoThe future of plant breeding techniques in the European Union 25 June 2014 Obtained through

Freedom of Information request by CEO

Several additional pieces of analysis were allocated to the Commissions Joint Research Centre (JRC)

EFSA Scientific opinion addressing the safety assessment of plants developed using cisgenesis and intragenesis 2012

httpwwwefsaeuropaeufrefsajournalpub2561

DG SANCO Background brief at the occasion of visit Mr Ladislav Miko to Keygene 26 January 2012 Obtained through Freedom of Information request

by CEO

DG SANCO Presentation on New Breeding Techniques at European Seed Association Annual Meeting 15 October 2012 Obtained through Freedom of

Information request by CEO

DG SANTE Email to NBT Platform 02 July 2015 Obtained through Freedom of Information request by CEO

European Parliament Follow up to the European Parliament resolution on ldquoPlant breeding what options to increase quality and yieldsrdquo (EP reference

number A7-00442014 P7_TA-PROV(2014)0131) 28 May 2014

BASF Letter to DEFRA 29 April 2013 Obtained through Freedom of Information request by GeneWatch

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

Finnish Board of Gene Technology Letter to Paolo Testori Coggi Director-General of DG SANCO 17 February 2014 Obtained through Freedom of

Information request by CEO

DG SANCO Letter to Finnish Board for Gene Technology 25 April 2014 Obtained through Freedom of Information request by CEO

NBT Platform two-pager April 2015 httpwwwnbtplatformorgbackground-documentsfactsheets2-pager-nbt-p

Bussink Michiel De strategie in Nederland Geen slapende honden wakker maken In Milieudefensie Magazine 1999-3

RTRS website Accessed 10 December 2015 httpwwwresponsiblesoyorgabout-rtrsgovernancetask-forcestask-for

Corporate Europe Observatory Roundtable on Responsible Soya - The certifying smokescreen 22 May 2012

httpcorporateeuropeorgsitesdefaultfilespublicationsrtrs_briefin

DG Trade Report from meeting with NBT Platform 07 June 2012 Obtained by Freedom of Information request by CEO

European Seed Association Position paper New Breeding Techniques ndash ensuring Progress and Diversity in Plant Breeding July 2012

httpswwweuroseedseusystemfilespublicationsfilesesa_1204462pdf

NBT Platform Fact sheet New Breeding Techniques Seizing the opportunity Version 2013

Cnudde F Dow Agrosciences Presentation Use of Zinc Finger Nucleases for plant breeding purposes May 2012 Obtained through Freedom of

Information request by CEO

Steinbrecher Ricarda Genetic Engineering in plants and the ldquoNew Breeding Techniques (NBTs)rdquo December 2015

httpwwweconexusinfopublicationgenetic-engineering-plants-and-new-

- httpswwwgrainorgesarticleentries588-gm-soybean-latin-america-s-

- httpslasojamatanetfilesparaguay-humanrights-reportpdf

Testbiotech Gene-editing and plants amp animals used in food production some technical socio-economic and legal aspects Backgrounder for Hearing on

ldquoNew Techniques for Plant Breedingrdquo in the EP Agriculture Committee 1 December 2015

httpwwwtestbiotechorgsitesdefaultfilesLegal20and20technical2

Fagan J Antoniou M Robinson C Earth Open Source GMO Myths and Truths 2014 httpgmomythsandtruthsearthopensourceorg

Greenpeace Twenty years of failure Why GM crops have failed to deliver on their promises November 2015

httpwwwgreenpeaceorginternationalGlobalinternationalpublication

NBT Platform two-pager April 2015 httpwwwnbtplatformorgbackground-documentsfactsheets2-pager-nbt-p

NBT Platform Email to DG Trade 18 May 2015 Obtained through Freedom of Information request by CEO Doc 2 A2D Trade

NBT Platform two-pager April 2015 httpwwwnbtplatformorgbackground-documentsfactsheets2-pager-nbt-p

EU Transparency Register Accessed 11 January 2016 httpeceuropaeutransparencyregisterpublicconsultationdisplaylobb

The lobbying activities covered by the register include all those that are ldquocarried out with the objective of directly or indirectly influencing the

formulation or implementation of policy and the decision-making processes of the EU institutions irrespective of where they are undertaken and of the

channel or medium of communication used for example via outsourcing media contracts with professional intermediaries think tanks platforms

forums campaigns and grassroots initiativesrdquo Article 7 httpeur-lexeuropaeulegal-contentENTXTHTMLuri=CELEX32014Q0919

Website NBT Platform Accessed 8 November 2015 Compared to a list provided in 2014 two members dropped off Cellectis Plant Sciences and Centre

RampD Nestleacute Tours httpwwwnbtplatformorg

DG SANCO Steering note for Mr Ladislav Miko at the occasion of a visit by Mr Hugo von Meijenfeldt Acting DG Environment Environment Ministry

Netherlands 15 November 2012

DG Trade Report from meeting with NBT Platform 07 June 2012 Obtained by Freedom of Information request by CEO

Inova Fruit is owned by five shareholders all large fruit auction companies 49 of shares are owned for instance by the Greenery that has over 1400

employees

For example Rothamsted Research website As accessed 11 January 2016 httpwwwrothamstedacuknewsnew-collaborative-research-project-gets

VIB website As accessed 21 December 2015 httpwwwvibbenlover-viborganisatiePaginasAlgemene-vergaderingaspx

ENERGYPOPLAR website As accessed 21 December 2015 httpwwwenergypoplareuinstitutionsphpid=40

NBT Platform two-pager April 2015 httpwwwnbtplatformorgbackground-documentsfactsheets2-pager-nbt-p

DG SANCO Notes of meeting with NBT Platform of 31 May 2012 06 June 2012 Obtained through Freedom of Information request by CEO

NBT Platform Proposed agenda for meeting on 22 June 2012 Obtained through Freedom of Information request by CEO

Schouten Henk Wageningen University and Research Center and Inova Fruit Presentation to European Commission Legal arguments to keep plants

from novel breeding techniques such as cisgenesis outside the GMO regulation 22 June 2012 Obtained through Freedom of Information request by CEO

Kempen F C Jung Genetic Modification of Plants Agriculture Horticulture and Forestry 2010 In Biotechnology in Agriculture and Forestry Springer

httpelibrarycomngUploadFilesfile0_10097pdf

Schuttelaar amp Partners was also hired for this project to draw up a communication plan ldquofor the acceptance and marketingrdquo of the cisgenic apple

National Academic Research and Collaborations Information System website As accessed 12 January 2016

httpwwwnarcisnlresearchRecordIDOND1310571

NBT Platform Email to DG SANCO 10 July 2012 Obtained through Freedom of Information request by CEO

17

18

19

20

21

22

23

24

25

26

27

28

29

30

31

32

33

34

35

36

37

38

39

40

41

42

43

44

45

46

47

48

49

DG Trade Report from meeting with NBT Platform 07 June 2012 Obtained through Freedom of Information request by CEO

DG Trade Report from meeting with Schuttelaar amp Partners on new breeding techniques 15 March 2012 Obtained through Freedom of Information

request by CEO

European Seed Association (ESA) Position paper Promoting and Enabling Innovation in Plant Breeding February 2014 Obtained through Freedom of

Information request by CEO

NBT Platform Legal Briefing Paper The regulatory status of plants resulting from New Breeding Technologies Version of 28 May 2013 Obtained

through Freedom of Information request by CEO

NBT Platform Summary of Legal Briefing Paper ldquoThe regulatory status of plants resulting fromNew Breeding Technologiesrdquo Obtained through Freedom

of Information request by CEO 22 May 2013 doc 512

The Directive 200118 (Annex 1B) lists two techniques ndash cell fusion and mutagenesis ndash for which an exemption has been granted and that are therefore

excluded from its scope As these two techniques predated the Directive by many years EU authorities assumed there was a lsquohistory of safe usersquo

The following documents exemplify the pro-deregulation arguments Each uses one or more of the points listed in the table

- European Technology Platform Plants for the Future Position paper New Breeding Techniques - Ensuring an Innovative and Diversified European

Agriculture September 2012 httpwwwepsoweborgfile1096

- European Seed Association Regulatory approaches to modern plant breeding - the case of mutagenesis and new gene editing technologies 20 July 2015

httpswwweuroseedseusystemfilespublicationsfilesesa_150543_0pdf

- CropLife International Position Paper Regulatory oversight of products developed through new breeding techniques 2014 httpscroplifeorgwp-

contentuploadspdf_filesRegulatory-Oversight-o

- NBT Platform Factsheet Oligonucleotide-Directed Mutagenesis accelerating innovation 2013 httpwwwnbtplatformorgbackground-

documentsfactsheetsfactsheet-oli

- NBT Platform Legal Briefing Paper The regulatory status of plants resulting from New Breeding Technologies Version of 28 May 2013

- Kraumlmer L Legal questions concerning new methods for changing the genetic conditions in plants Legal analysis commissioned by Arbeitsgemeinschaft

baumluerliche Landwirtschaft (AbL) Bund fuumlr Umwelt und Naturschutz (BUND) etc September 2015

httpwwwtestbiotechorgsitesdefaultfilesKraemer_Legal20questions

- Spranger TM Legal Analysis of the applicability of Directive 200118EC on genome editing technologies Commissioned by the German Federal Agency

for Nature Conservation October 2015 httpbfndefileadminBfNagrogentechnikDokumenteLegal_analysis_of_g

- Cotter J Zimmermann D Van Bekkem H Greenpeace Applications of the EU and Cartagena definitions of a GMO to the classification of plants

developed by cisgenesis and gene-editing techniques 2015 httpwwwgreenpeacetogreenpeacewp-contentuploads201511Applicati

- Reseau Semences Paysannes Confederation Paysanne et al Statut juridique des produits issus des nouvelles techniques de modification geacuteneacutetique des

plantes

DG SANCO Notes from meeting with NBT Platform 21 March 2014 Obtained through Freedom of Information request by CEO

NBT Platform and ETP Plants for the Future Meeting report Multilateral meeting lsquothe future of plant breeding techniques in the European Unionrsquo

Obtained through Freedom of Information request by CEO 25 June 2014

Ibid

Dow Agrosciences and DG SANCOJRC Emails April 2012 and July 2013 Obtained through Freedom of Information request by CEO

DG SANCO Internal email 8 July 2013 Obtained through Freedom of Information request by CEO

Corporate Europe Observatory and Inf OGM TTIP released emails show biotech seeds on the trade talks table 2 July 2015

httpcorporateeuropeorgfood-and-agriculture201507ttip-released-em

European Commission Letter to Competent Authorities 5 June 2015 Obtained through Freedom of Information request by CEO

Cibus Europe Letter to DG SANCO January 2015 Obtained through Freedom of Information request by CEO

Schuttelaar amp Partners Letter to Commissioner Vytenis Andriukaitis 1 December 2014 Obtained through Freedom of Information request by CEO

NBT Platform Email to Mr Ladislav Miko (DG SANTE) 26 February 2015 Obtained through Freedom of Information request by CEO

NBT Platform Email to DG Trade 18 May 2015 Obtained through Freedom of Information request by CEO

According to Agrafacts the non-paper was authored by German UK Irish and Spanish authorities

Non-paper on the regulatory status of plants generated by oligonucleotide-directed mutagenesis (ODM) 21 May 2015 Obtained through Freedom of

Information request by CEO

BVL Legal interpretation to DG SANTE 28 September 2015 Obtained through Freedom of Information request by CEO

DG SANTE Reply to Vlaams Instituut voor Biotechnologie (VIB) 9 July 2015 Obtained through Freedom of Information request by CEO (doc 24 a2d3)

Vlaams Instituut voor Biotechnologie (VIB) Letter to Mr Ladislav Miko (DG SANTE) 10 June 2015 Obtained through Freedom of Information request by

CEO

DG SANTE Reply to Vlaams Instituut voor Biotechnologie (VIB) 9 July 2015 Obtained through Freedom of Information request by CEO

Vlaams Instituut voor Biotechnologie (VIB) Email to DG SANTE 6 July 2015 Obtained through Freedom of Information request by CEO

VIB Fact series Een schimmelresistente aardappel voor Belgieuml December 2014

50

51

52

53

54

55

56

57

58

59

60

61

62

63

64

65

66

67

68

69

70

71

72

73

74

Food and agriculture

Attached files Attached files

1_briefing_visit_keygenepdf

6pdf

13_presentation_at_esa_-_15-10-2012pdf

14_briefing_visit_nl_dg_2pdf

26_letter_from_fi_registered_versionpdf

30_bto_meeting_with_nbpt-2_registered_versionpdf

34_reply_to_finland_25-4-2014_registered_versionpdf

36_nbt_platform_multilateral_meeting_25_06_2014_steering_note_registered_versionpdf

42_e-mail_dow_agro_to_jrc_-_10-4-2012pdf

431_presentation_cnudde_31-5-2012pdf

44_bto_meeting_31-5-2012pdf

45_proposed_agenda_meeting_22-6-2012pdf

462_ppt_schouten_22-6-2012pdf

51_e-mail_nbt_platform_31-5-2013pdf

511_legal_briefing_paper_-_28-5-2013pdf

512_summary_legal_paper_22-5-2013pdf

513_nbt_factsheetspdf

53_e-mail_from_dow_agro_to_sanco_2-7-2013pdf

54_internal_e-mail_dg_sanco_8-7-2013pdf

561_esa_position_paper_-_fev_2014pdf

57_invitation_to_the_meeting_on_the_future_of_plant_nbts_in_the_eu_25_06_2014pdf

nbt_platform_multilateral_meeting_ares20144089348_-_signed_version_-_third_batchpdf

9pdf

6pdf

12pdf

18pdf

17_20150610_vib_letter_redactedpdf

18_20150615_lettre_autorites_competentes_redactedpdf

21_20150702_reply_to_nbtp-redactedpdf

24_20150709_reply_to_vib_redactedpdf

27_20150722_vib_redactedpdf

28_bto_-_meeting_l_miko_with_new_breeding_technique_platform_-_27_april_2015_redactedpdf

atd_2015-5344_-_doct_2pdf

atd_2015-5344_-_doct_7pdf

atd_2015-5344_-_doct_8pdf

ares20155217184annex-ms_non_paperpdf

httpwwwvibbenleducatieDocumentsVIB_dossier_20schimmelresistent

EASAC Statement on New Breeding Techniques July 2015 httpwwweasaceufileadminPDF_sreports_statementsEasac_14_NBTpdf

EASAC Planting the Future - opportunities and challenges for using crop genetic improvement technologies for sustainable agriculture June 2013

httpwwweasaceufileadminReportsPlanting_the_FutureEASAC_Planting

However one third of the working group are also member of PRRI an industry-minded lobby group of public scientists

Corporate Europe Observatory PRRI - Are these public researchers 2008 httpcorporateeuropeorgfood-and-agriculture200806prri-are-these-p

European Parliament Committee on Agriculture Hearing on ldquoNew Techniques for Plant Breedingrdquo 1 December 2015

httpspolcmssecureeuroparleuropaeucmsdatauploadd35d2641-ab77-49

Furthermore Schuttelaar amp Partners now lists only one client (Grodan a supplier to the horticulture sector) This is in sharp contrast to the lobby firmrsquos

own website where 11 clients from the food and biotech sectors are listed as examples of ldquocurrent and recent clientsrdquo

Schuttelaar amp Partners website As accessed 13 December 2015 httpwwwschuttelaar-partnerscomclients

EU Transparency Register website As accessed 15 November 2015 (No longer in public domain available from CEO)

EU Transparency Register Accessed 16 January 2016

Dorotheacutee Andreacutee DG SANTE Comment at EP Agriculture Committee hearing 1 December 2015

75

76

77

78

79

80

81

0

14_09-28_letter_de_redactedpdf

Tag Tag

genetically modified crops

GMOs

Belgian showfield of DutchGM DuRPhpotatoes

Related Latest

REPORT

Of apples and potatoesthe Dutch lobby for thederegulation ofcisgenesisFEBRUARY 2ND 2016 THE POWER OF

LOBBIES FOOD AND AGRICULTURE

The voice of the Dutch Government has been

loud and clear in Brussels on the issue of

cisgenic plants The Dutch have waged a

sustained campaign to have new GM

techniques ndash and in particular cisgenesis ndash

excluded from EU GMO regulations Several

Dutch ministries the Dutch Parliament the

Dutch Permanent Representation in Brussels

and Dutch MEPs have energetically pursued

this goal

STORY

Canadian company railroads EUdecision-making on new GM

FEBRUARY 2ND 2016 THE POWER OF LOBBIES FOOD AND

AGRICULTURE

At least one developer of new GM crops ndash

Canadian-based Cibus ndash has attempted to

bypass the European policy process by

presenting policy makers with a fait accompli

decisions by individual Member States on the

regulatory status of new techniques as well as

prematurely-launched trials of new GM crops

STORY

EU review of weedkillerglyphosate adds secrecyto controversy

JANUARY 14TH 2016 EFSA FOOD AND AGRICULTURE

More than 80 per cent of the national experts

involved in the EUs official assessment of

glyphosate refused to have their names

disclosed to the public

STORY

Solutions COP21Climate SmartAgriculture boostingthe technofix

DECEMBER 10TH 2015 CLIMATE AND ENERGY FOOD AND

AGRICULTURE

ldquoIf you like greenwashing clap your handsrdquo

1 of 321 of 32 next rsaquo

Corporate Europe Observatory

(CEO) is a research and campaign

group working to expose and

challenge the privileged access

and influence enjoyed by

corporations and their lobby

groups in EU policy making

Read more

CEO relies on grants and

donations to carry out our

research and campaign work By

making a donation or becoming a

friend of CEO you help to

support our efforts to expose

corporate lobbying increase

transparency and urge greater

democratic accountabililty in the

EU

Or

All written content on this

website is licensed under a

Creative Commons Attribution-

NonCommercial-ShareAlike 30

Unported License

Page 2: FOROEUROPA - Biotech lobby’s push for new GMOs to escape … · 2016-02-04 · With respect to cisgenesis and intragenesis, EFSA concluded that while intragenic plants would generate

What are the new GM techniques

The list of new GM techniques currently being considered by the

Commission includes Oligonucleotide-Directed Mutagenesis

(ODM) Zinc Finger Nuclease technology (ZFN) comprising ZFN-1

ZFN-2 and ZFN-3 Cisgenesis and Intragenesis Grafting

Agroinfiltration RNA-dependent DNA methylation (RdDM) and

Reverse Breeding Most of these techniques are also called gene

editing editing techniques instead of introducing genetic traits

from another organism the genome can be directly rewritten in

the cells

Indeed companies appear to be deliberately investing in

techniques designed to circumvent the EUs GMO regulations As

an expert for the US Consumer Union has noted ldquoAll these new

technologies are ways to weasel around a very narrow definition of

transgenic I would consider that misleading to the publicrdquo An

industry lobby document sent to EU decision makers in 2013 could

not be clearer about the industrys motivation to develop new GM

techniques they were developed ldquoas a response to the de facto

moratorium on GMOs that currently exists in Europerdquo These

investments and the many related patent applications now

demand a financial return

EFSA opinions on three techniques

and consumer choice Therefore calls from farmers and environmental groups to regulate the new GM are increasing The

techniques in question each bring their own set of risks and uncertainties Technical reports and legal analyses by government

bodies and NGOs have concluded that GM 20 should not escape the EU GM regulations Whilst some risks are similar to those

associated with GM 10 there are also serious additional concerns

To further its cause industry has set up a dedicated EU-level lobbying vehicle ndash the New Breeding Techniques Platform ndash with the

mission of having as many of the new GM t echniques as possible excluded from EU GM regulations This platform is run by

Schuttelaar amp Partners a Dutch lobby and PR firm with a shady reputation for pro-GM lobbying At the same time individual

companies have been pressing various European governments to clarify the legal status of the new genetic engineering techniques

while announcing plans to field trial them in those countries Furthermore certain governments have been actively advocating the

deregulation of new GM techniques at the EU level

The ongoing negotiations around the Transatlantic Trade and Investment Partnership (TTIP) are an additional source of political

pressure on European decision makers In this context industry lobby groups have presented the regulation of new GM techniques

as a trade concern to both US and EU officials claiming that the innovative nature and competitiveness of the European plant

breeding (read biotech) sector is at stake

After contemplating this question for eight years the Commission finally plans to publish a draft decision in February 2016 This

briefing based on documents released by the European Commission following freedom of information requests illuminates the

efforts made over the past three years by the industry lobby to have the new GM techniques deregulated In addition a first case

study highlights the Dutch lobby campaign for the deregulation of cisgenesis and a second one looks at Canadian company Cibuss

push for the deregulation of its ODM oilseed rape

2 A lengthy process

The European Commission turned its attention to the new GM techniques eight years ago setting up a New Techniques Working

Group (NTWG) in October 2007 to assess whether the GM techniques listed above give rise to products falling within the scope of

the GMO legislation However its final report showed that the working group was divided on the regulatory status of some of the

techniques therefore leaving the Commission with no clear plan of action

In parallel to the analysis carried out by this Working Group the

Commission requested opinions from the European Food Safety

Agency (EFSA) about the risks posed by cisgenesis intragenesis

and Zinc Finger Nuclease 3 and whether existing risk assessment

methods were adequate for evaluating them

In 2012 the Commission reported that it was working with

member states to find the best way forward in clarifying the

regulatory status of the new techniques In a presentation to

the European Seed Association the Commission claimed to be

looking not only at the legal aspects but also at ldquosafety

considerations the approach in third countries the chances and

risks involved and the view of European plant breedersrdquo

Just months later at a meeting with the industry-led NBT

Platform the Commission had changed course It was later

clarified that due to ldquothe absence of consensus amongst the main

political EU actors reflecting the public hostility to GMOsrdquo the

Commission had opted for a legal guidance document

interpreting Directive 200118 rather than for new legislation

This means that the European Parliament plays no formal role

and that member states are expected to follow the Commissions

recommendations In the case of disagreement the European

Court of Justice has the final say

The Commission has time and time again postponed the

1

2

3

4

5

6

7

8

9 10

12

13

14

With respect to cisgenesis and intragenesis EFSA concluded that

while intragenic plants would generate similar risks to transgenic

ones cisgenic plants could be compared to conventionally bred

plants However the agency clarified that ldquoall of these breeding

methods can produce variable frequencies and severities of

unintended effects The frequency of unintended changes may

differ between breeding techniques and their occurrence cannot be

predicted and needs to be assessed case by caserdquo Furthermore

EFSA opined that ZFN-3 requires in principle the same risk

assessment that is currently applied to GMOs but that on a case-

by-case basis ldquolesser amounts of data may be neededrdquo for plants

developed using this technique

Schuttelaar amp Partners no novice to below-the-radar lobby campaigns for biotech clients

In 1995 the firm was hired by Monsanto to secure a smooth

introduction for the first imports of a GM crop ndash Monsantos

herbicide-tolerant Roundup Ready soy ndash to Europe Schuttelaar

amp Partners was set up by Marcel Schuttelaar a former campaigner

for Friends of the Earth Netherlands Familiar with Monsantos

adversaries as an insider and an outsider he was the ideal man for

the job The strategy chosen was to lsquolet sleeping dogs lie carefully

injecting tranquillising messages into the right ears in order to

avoid a sudden outcry from media and consumer organisations

The lobby firm ndash not hindered by a lack of evidence - stressed the

benefits of Roundup Ready soy such as reduced pesticide use (a

claim that has proven to be untrue)

deadline for delivering the legal guidance document In response

to the many queries from industry and member states on its

progress the standard response has been that assessing the new

techniques in the light of Directive 200118 ldquo is complex and

requires a thorough technical and legal analysisrdquo

As the Commission indicated the member states were divided

Certain EU governments including the UK the Netherlands and

Germany pressured the Commission to deregulate one or more

of the techniques The Netherlands for instance has invested

considerable public research funding in promoting the cisgenic

GMOs developed by Wageningen University and the

Commission has been pressured by Dutch Ministries the

Permanent Representation in Brussels the national parliament

and Dutch MEPs (See case study Of apples and potatoes the Dutch lobby for the deregulation of cisgenesis)

Not surprisingly corporations have been itching to get started on field trials of the new GM crops Between 2012 and 2014 BASF

and the Canadian company Cibus (among others) approached several member states including the UK Sweden and Finland to

ascertain the regulatory status of one of the techniques ndash Oligonucleotide-Directed Mutagenesis (ODM) ndash and to obtain clearance

to field trial ODM herbicide-tolerant oilseed rape without having to undergo the regulatory risk assessment required of GMOs

(See case study Canadian company railroads EU decision making on new GM)

This resulted in the Finnish government complaining to the Commission about the lack of clarity of direction on ODM leaving

the national competent authorities ldquoin a legally challenging positionrdquo since they were obliged to respond to the companies

Helsinki gave the Commission an April 2014 deadline to respond but again the Commission told them to be patient

3 New Breeding Techniques Platform corporations unite to deregulate GMOs

The trail of Freedom of Information requests over the past three years to the European Commission illuminates industrys efforts

to have new genetic engineering techniques escape regulation These efforts are coordinated by the New Breeding Techniques

(NBT) Platform whose objective is to have ldquoall NBTs ndash or as many techniques as possible ndash exempt from GM legislationrdquo The

Brussels office of Dutch lobby and public relations firm Schuttelaar amp Partners (their motto ldquoscience-based consultancy with

senserdquo) was hired to chair the NBT Platform and coordinate its lobby activities

This was perhaps not a surprising choice as company materials show that Schuttelaar amp Partnersrsquo recent clientegravele includes various

biotech industry actors whose interests are served by the NBT Platform (for example Syngenta Bayer CropScience Dow

AgroSciences biotech lobby association EuropaBio and Inova Fruit) Also the firm has not shunned highly damaging industry

campaigns in the past its first triumph was tricking decision makers into allowing Monsantos herbicide-tolerant soy to flood the

European market (See Box Schuttelaar amp Partners no novice to below-the-radar lobby campaigns for biotech clients)

Any self-respecting PR firm designing a lobbying campaign will

start off by rebranding its clients product and developing a new

lexicon to pitch it to decision makers

The NBT Platform with its very name has rebranded the new

GM techniques as new breeding techniques to make them

sound different from genetic engineering Not without success

the European Commission and other regulatory bodies have fully

adopted this term in their communication on the topic Angelika

Hilbeck senior researcher at the Swiss Federal Institute of

Technology says ldquoNew breeding techniques is a misleading

term precisely because the users of these techniques aim to

avoid any breeding They simply allow the maintenance of a

successful market variety and the improvement of an agronomic

problem that primarily arises from monoculture production

methods that promote disease and the prevalence of pests The

11

15

16

17

18

19

20

By subtly expanding the European market Schuttelaar amp Partners

helped pave the way for the further expansion of GM soy

monocultures in South America Ironically 15 years later the firm

was hired by and participated in the Round Table on Responsible

Soy (RTRS) which includes Monsanto in its membership The

RTRS is a voluntary labelling scheme that certifies GM Roundup

Ready soy as responsible although its empty criteria do nothing

to protect local communities or reduce deforestation and pesticide

use

New GM same old pitch

So why do we need a new generation of GM The NBT Platform

and other deregulation advocates echoe the arguments in favour of

introducing GM crops 20 years ago in their pitch for the new GM

techniques They invariably cite some of the key

challenges faced by society today notably ldquorapid world population

growth climate change and increasing scarcity of resources such

as soil and waterrdquo New GM techniques it is said will come to

the rescue by massively improving the precision and speed of the

plant breeding process Important objectives allegedly include pest

resistance and drought tolerance Yet the very first new GM crop in

the pipeline developed by the Canadian company Cibus is another

herbicide-tolerant oilseed rape Herbicide-tolerant GM crops have

waged social and environmental havoc in the countries where they

are mass produced Many GM 20 patent applications are related

to traits such as herbicide-tolerance insecticide production and

changed oil composition - the same as GM 10 Furthermore the

claims about the benefits of GM 10 have been refuted time and

again

products will be sold under the same familiar names except they

are now patented and ndash if industry gets its way - not labelled as

GM The techniques are non-innovative and just like GM 10

are primarily a business modelrdquo

Other labels in the new lexicon such as gene editing or

genome editing are used to emphasise surgical precision and to

suggest absolute technological control of the genetic engineering

process However as Hilbeck points out precision in changing

an organisms genetic makeup is not equivalent to safety if you

do not fully understand what you are changing and the knock-

on impacts ldquoIts like changing letters in words and words in text in a language one does not understand That can be done with

precision and control yet with complete oblivion to the meaningrdquo she says

Another key ingredient is to develop a narrative that tells how indispensable the product will be for the greater good ndash even if you

cant come up with anything new (See box New GM same old pitch)

Schuttelaar amp Partners describes the work of the NBT Platform

as providing decision makers with ldquoindependent science-based

informationrdquo on the techniques and generating awareness about

ldquotheir widespread benefitsrdquo for the European economy But

the NBT Platform is far from independent with the private

sector making up the bulk of its membership and providing most

of the funding The membership fee structure as provided on

the Platforms website lists annual subscription fees of euro7000

for Small and Medium-sized Enterprises (SMEs) euro22500 for

large companies and euro2500 for scientific institutions

However none of this is evident from the EU Transparency

Register entries of the NBT Platform and Schuttelaar amp Partners

In fact the entries of both parties exemplify the often

meaningless incomplete and incorrect information provided by

corporations and lobby firms to this register In this case the

NBT Platforms first listing in the Transparency Register is from

April 2015 at least three years after its foundation The

connection to Schuttelaar amp Partners is not mentioned and

neither the Platform members nor the funding sources are

disclosed (Also see box Transparency register generates

confusing and incorrect data on NBT Platform)

Transparency register generates confusing and incorrect data on NBT Platform

In the EU Transparency Register the NBT Platform claims that its lobby expenses total a mere euro50000-99999 per year This figure is

not very meaningful since every entity can invent its own way to calculate lobby expenses when signing up to the register As the

Platforms overall budget is not disclosed lobby costs might in fact be much larger Furthermore the NBT Platform entry reports only a

05 FTE workload dedicated to the wide range of lobby activities falling under the scope of the register Schuttelaar amp Partners Director

Edwin Hecker is named as chair of the Platform and the number of lobbyists with permanent accreditation to the European Parliament

is registered as zero However in Schuttelaar amp Partners own entry to the EU Transparency Register Hecker is mentioned as one of ten

company employees holding a permanent accreditation pass to the European Parliament

There is more information available on the NBT Platformrsquos own website but this was only launched in July 2015 The site lists the

following members Syngenta KeyGene Inova Fruit SESVanderHave Rijk Zwaan Meiogenix SweTree Technologies Semillas Fitoacute

Enza Zaden Rothamsted Research VIB (Flemish Biotechnology Institute) Fondazione Edmund Mach and the John Innes Centre

Commission documents however indicate that Dow Agrosciences and Bayer CropSciences vegetable seed business Nunhems were

21

22

23 24 25 26

27

28

29

30

31 32

33

34

35

36

also at some point members of the Platform and in any case attended NBT meetings

The NBT Platform does not let an opportunity pass to stress the interests of SMEs and research institutes in its lobby to get new

GM deregulated However taking the EU definition of a SME as a company with fewer than 250 employees only three Platform

members qualify KeyGene Meiogenix and SweTree Technologies Furthermore some of the lsquopublicrsquo research institutes that the

NBT Platform represents have strong financial ties with industry For instance Rothamsted Research (UK) has many joint projects

with agribusiness corporations And no less than one third of the general council membership of the Flemish Biotechnology

Institute (VIB) is made up of industry representatives including Syngenta and Bayer

Indeed it is important to note that both biotech SMEs and (semi-) public research institutes often play the role of technology

suppliers for big multinationals SweTree Technologies for example is engaged in the development of GM trees and claims to have

applied for 75 patents in that field Some of these products have already been licensed to BASF and SweTree Technologies claims to

collaborate with the corporation in several areas

4 Multi-phased lobby campaign against EU GMO regulation

The NBT Platformrsquos website clearly delineates the four phases of its campaign to give the death blow to GMO regulation for new

GM products

Source NBT Platform website

Following the creation of the NBT Platform in the first phase the second phase in the industryrsquos lobby campaign to the European

Commission was characterised by repeated efforts to showcase the new techniques and their claimed benefits as well as the

provision of technical and legal arguments for why they should go unregulated

In the spring of 2012 for example Schuttelaar amp Partners teamed up to chair two meetings presenting new GM techniques to staff

from DG SANCO DG Trade and DG Research and Innovation Dow presented Zinc Finger Nuclease (ZFN) technology Rijk

Zwaan introduced agroinfiltration and reverse breeding BayerNunhems explained cisgenics KeyGene made a pitch for ODM and

VIB put forward grafting on GM root stock Syngenta and Inova Fruit were also present at the meetings

In addition a legal argumentation as to why the EU should not regulate ODM and cisgenics techniques in particular was presented

by Wageningen University plant researcher Henk Schouten who was also wearing his hat as lobbyist for Inova Fruit Inova Fruit

owned by large Dutch and Flemish fruit traders contracted the private arm of Wageningen University to develop cisgenic apple

varieties Both Wageningen University and Inova Fruit clearly have commercial interests in getting cisgenesis deregulated This

shows the involvement of Wageningen University in private interest lobbying despite its public denial of this kind of activity (See

case study Of apples and potatoes the Dutch lobby for the deregulation of cisgenesis)

In May 2013 the NBT Platform presented the Commission with

37 38

39

40

41

42

43

44 45

46

47 48

Trade concerns (1) avoiding disruptions at all costs

In lobbying the Commission DG Trade was not left out In a first

meeting in March 2012 Schuttelaar amp Partners raised their clientsrsquo

concerns about ldquothe legislative uncertaintyrdquo for new GM

techniques and added that in this field ldquothe EU occupies the

second place in the world for patent applications with the UK and

the Netherlands contributing most significantlyrdquo In late May

2012 Schuttelaar amp Partners staged a second larger meeting

attended by DG SANCO DG Trade and ldquoNBT Platform membersrdquo

Dow Agrosciences VIB KeyGene Syngenta Bayer CropScience

Rothamsted Research Rijk Zwaan and Wageningen University

Their message did not fall upon deaf ears After the first meeting a

DG Trade official concluded that his DG would ldquohave to ensure

that any measuresolution proposed will not result in trade

disruptionsrdquo And furthermore he reported ldquoI was reassured by my

SANCO counterparts that the trade angle will be taken into

account when deciding on the Commissionrsquos line to takerdquo

The European Seed Association announced to DG SANCO that it

wanted new GM techniques deregulated and specifically attacked

the EU traceability and labelling requirements for their ldquopotential

to hamper free traderdquo

its piegravece de reacutesistance the industryrsquos own lsquolegal interpretationrsquo of

the regulatory status of new GM techniques This was based on

a sort of questionnaire consisting of seven main questions (and

many subquestions) that it is explained must all be answered in

the affirmative in order for a product to be regulated as a GMO

This methodology was carefully designed to ensure the desired

outcome that all of the new GM techniques in question should

be unregulated and by extension untested and unlabelled

Source NBT Platform website

Question 3 and 4 aim to twist the definition of a GMO in EU Directive 200118 which is ldquoan organism with the exception of

human beings in which the genetic material has been altered in a way that does not occur naturally by mating andor natural

recombinationrdquo Using industrys methodology most of the new techniques would escape regulation as they can provide a negative

answer to one of these two questions The Platform analysis also argues that some of the new GM techniques are simply a

variation of mutagenesis (a technique that had long been in use when Directive 200118 was developed and that was explicitly

excluded from its scope) Furthermore the industry approach aims to undermine the process-based nature of the Directive as

described earlier

The arguments put forward by the NBT Platform are at the core of industrys rationale for the deregulation of new GM These

points or variations on them can also be found in lobby documents produced by the European Seed Association (ESA) the

European Plant Science Organisation (EPSO) the pesticide lobby group Croplife International and the Flemish biotech research

institute VIB

The pro-deregulation interpretation of the scope of Europersquos GM laws has been met with wide-ranging criticism Counter-

arguments have been provided by German federal agencies (for example the opinion by Professor Tade Matthias Spranger for BfN

the German Federal Agency of Nature Conservation) a legal analysis by Professor Ludwig Kraumlmer as commissioned by German civil

society and assessments by Greenpeace farming and other environmental groups Similarly industryrsquos attempt to have new GM

49

50

51

52

53

54

55

declared safe by design and therefore exempt from regulatory risk assessment has been countered by the Austrian Environmental

Agency and various non-governmental organisations

The legal case that new GM techniques should be covered by the current regulations is in fact crystal clear

The central purpose of Directive 200118 on the deliberate release of GMOs is to protect human health and the environment from

the release of genetically modified organisms The Directive clearly provides for the advent of new GM techniques which rely upon

in vitro methods to directly modify genomes These are the very type of techniques that EU law covers with its process-based

approach (where the technique used decides if the regulations apply) That process-based regulation and the precautionary

approach that lies at the heart of the directive are justified because of the unintended and unexpected effects of both GM 10 and

GM 20 techniques Techniques that have been developed since 2001 (or that didnt have any commercial application prior to 2001)

cannot be regarded as industry argues the same as traditional mutagenesis techniques that were exempted on the grounds of a

claimed history of safe use when the EU regulations were introduced

The key arguments from industry and counter-arguments are summarised in the following table

Table Key industry arguments for the deregulation of new GM techniques

Industry argument Response

1 ldquoNew GM is just l ike traditional plant1 ldquoNew GM is just l ike traditional plant

breedingrdquobreedingrdquo

Products from new GM are just like traditionally bred

plants since ldquono foreign DNA is usedrdquo Industry seeks to

reframe the legal interpretation of a GMO in this way

because many of the new techniques do not necessarily

use DNA from another species or use genetic material

other than DNA

In EU law a GMO does not need to contain foreign DNA to qualifyIn EU law a GMO does not need to contain foreign DNA to qualify

as a GMOas a GMO

The Directive refers to ldquoan organism hellipin which genetic material has been

altered in a way that does not occur naturally by mating andor natural

recombinationrdquo The new techniques directly modify an organismrsquos genetic

material without involving mating and are therefore genetic engineering In

addition the Directive also qualifies the introduction of other types of genetic

material than DNA as GM

2 ldquoJust because a GM technique is used does2 ldquoJust because a GM technique is used does

not mean that the product is legally a GMOrdquonot mean that the product is legally a GMOrdquo

If there is no GM material present in the final product

it should not be treated as a GMO This is an attack on

the process-based (technique-based) nature of the

Directive and would mean that products of several

methods that do involve GM would be exempt

The EU has The EU has recognisedrecognised that the GM that the GM technique usedtechnique used to to changechange an an

organisms organisms does does mattermatter

Itrsquos the genetic engineering process that can lead to unintentional alterations

of the genetic material giving rise to concerns regarding food and

environmental safety These concerns remain even if the genetic engineering

agent is subsequently removed

3 ldquoGene editing techniques are a form of3 ldquoGene editing techniques are a form of

mutagenesis rdquomutagenesis rdquo

Mutagenesis is excluded from the scope of the

Directive as it was assumed to have a history of safe

use

New gene editing techniques are different and have no histor y ofNew gene editing techniques are different and have no histor y of

safe usesafe use

They are different from the mutagenesis techniques (chemical and radiation)

referred to in the Directive

4 ldquoNew GM is safe by designrdquo4 ldquoNew GM is safe by designrdquo

The claim is that the genetic interventions are precise

and targeted and therefore safe This is reflected by the

terms used gene or genome editing

New GM techniques can have multiple unintended and unexpectedNew GM techniques can have multiple unintended and unexpected

results results

New GM methods pose very similar types of risks as GM 10 and should be

regulated at minimum in the same way as existing GMOs in order to protect

the environment and public health Precision in changing the genetic makeup

of an organism does not equate safety if you do not fully understand the

impacts

5 ldquoDetection is impossiblerdquo5 ldquoDetection is impossiblerdquo

Industry claims that detection methods will not be able

Detection methods are evolving as are genetic engineeringDetection methods are evolving as are genetic engineering

techniques techniques

56 57

Trade concerns (2) TTIP kicks in

Another line of argument pursued by the NBT Platform is the

comparison of how new GM techniques are regulated ndash or not ndash in

other parts of the world cumulating in the suggestion that a

stronger level of regulation in the EU will create trade barriers

In the context of TTIP the way the US deals with the new

techniques is of particular interest For example US-based

multinational Dow informed DG SANCO in 2013 of the decision by

the US Department of Agriculture (USDA) to not regulate Dows

ZFN-1 maize The Commission later reflected however that the

US Food and Drug Administration (FDA) ldquoremains rather vaguerdquo on

the issue It should be noted that the US hardly regulates GMOs

as such There are no formal data requirements when it comes to

safety testing and biotech companies voluntarily provide whatever

information they please

Emails released by the Commission provide evidence that the (de-

)regulation of new GM techniques was indeed discussed in a March

2014 TTIP-related meeting in Washington Despite repeated claims

at the time by the Commission that ldquoGM is not on the tablerdquo US

and EU authorities sat together with seed industry lobby groups

from both sides of the Atlantic (including the European Seed

Association)

to tell the difference between a new GM and a

traditionally-bred product

While distinguishing some new GM products from non-GM products may

currently be difficult this is very likely to change in the future

6 ldquoApplication of the precautionar y principle6 ldquoApplication of the precautionar y principle

should be reconsideredrdquoshould be reconsideredrdquo

Industry claims that since there is less uncertainty

related to new gene editing techniques than with

mutagenesis using radiation or chemical mutagens and

since the precautionary principle is about uncertainty it

should not be applied to new GM techniques

Precautionar y principle should be respectedPrecautionar y principle should be respected

The precautionary principle and the process-orientated approach to risk

assessment as established under EU law can only be implemented if the new

methods are covered by the Directive

5 Last phase lobbying

The third phase of the industry campaign indicated in the graph by lsquoPoliticsPublic Affairsrsquo (read Lobby) kicked in with a so-

called multi-stakeholder meeting held on 25 June 2014 lsquoThe future of plant breeding techniques in the European Unionrsquo was a

co-production of the NBT Platform and the industry-driven European Technology Platform Plants for the Future However the

NBT Platform cast a narrow net when inviting lsquostakeholdersrsquo on its list were the Member States Competent Authorities the

Commission and companies and their lobby associations (eg the European Seed Association farming lobby Copa-Cogeca and so

forth) Absent were environmental and consumer NGOs sustainable farming organisations and the like

The industry campaign escalated during this phase with dire predictions of economic collapse and job losses following the

eventual regulation of new GM According to the NBT Platform multi-stakeholder meeting report for example industrial farming

group Copa-Cogeca said that ldquooverly strictrdquo regulation would ldquoincrease unfair competitionrdquo for farmers In turn the European Plant

Science Organisation (EPSO) insisted that the current legal uncertainty was causing ldquointelligence leakagerdquo and destroying jobs

while another participant went as far as to warn that this ambiguity would lead to the ldquocomplete extinctionrdquo of a large part of the

plant breeding sector in Europe

By the start of 2015 the Commission appeared close to reaching

a decision on new GM techniques and things were starting to

heat up

In the spring the German Government decided to take matters

into its own hands It determined that Cibus ODM oilseed rape

did not qualify as a GMO so that field trialling could proceed

with no regulation or monitoring In response the Commission

quickly sent letters to Germany and all EU member states asking

them to ldquoawait as much as possible the outcome of the

Commission legal interpretation before authorising a deliberate

release of organisms obtained with new plant breeding

techniquesrdquo since ldquothe deliberate release of products which are

subject to the rules of the EU GMO legislation without

appropriate prior authorisation is illegalrdquo (See case study

Canadian company railroads EU decision making on new GM)

But Cibus also informed the Commission that as its product was

already being grown in the US ldquothe harvested material is used

like any other crop and likely entering the international

commodity chainrdquo According to the company the possibility of

this unauthorised GM oilseed rape being imported into the EU

could therefore not be excluded

Following the May 2014 elections a new Commissioner in charge

of DG SANTE (previously called SANCO) was installed the

Lithuanian Vytenis Andriukaitis The NBT Platform set the

58

59

60

61

62

63

64

65

66

necessary liaison efforts into motion and set up a meeting that took place in July 2015 The Platform also shifted focus to liaise

and gather information from EU member states and sought a meeting with the Commission (DGs SANTE AGRI and Trade) to

report back on these contacts

Furthermore at two occasions in 2015 GM developers got assistance from certain member states that have also been peddling a

pro-deregulation agenda with Brussels In May 2015 a lsquonon-paperrsquo authored by Germany the UK Ireland and Spain argued for the

deregulation of the ODM technique in particular using the same arguments as put forth by industry to argue that ldquoODM is a

variation of mutagenesisrdquo

In September the German food safety agency BVL in a joint exercise with its UK and Irish colleagues sent an interpretation of the

definition of a GMO in Directive 200118 to the Commission This document precisely echoes the industry discourse that a

product should only be regulated under EU GMO laws if it is produced by a GM process and if the result is a product that could

not have been achieved in a lsquonaturalrsquo way

Flemish biotechnology institute (VIB) and EASAC join the chorus

In this last phase corporate-backed research institutes like the Flemish VIB also stepped up their efforts in order to defend their

commercial interests On 5 June 2015 the VIB met with the Commission to discuss a number of new techniques Although the list

has not been disclosed following freedom of information requests according to the VIB ldquo the examples given represent concrete

business opportunities and vulnerable information from the viewpoint of competitionrdquo It appears likely from the Commission response

and a related email exchange on the topic that the VIB is eyeing cisgenesis and certain gene editing techniques VIB has an obvious

commercial interest in the deregulation of cisgenesis after having put its money on turning the failed Dutch cisgenic potato into a

Belgian specialty a blight-resistant Bintje a well known potato variety widely used for the countrys famous fries

Moreover in a remarkable statement addressed to the Commission in July 2015 the European Academies Science Advisory Council

(EASAC) also backed industrys views Their political demands dovetail with those of industry GMOs should be allowed to escape

regulation ldquowhen they do not contain foreign DNArdquo that GM products should be regulated only by trait and not technique and that the

use of the precautionary principle in GM regulation should be reconsidered The statement is based on the conclusions of an earlier

EASAC report Planting the Future This report was composed by a working group of experts acting in individual capacity nominated

by member academies of EASAC

Meanwhile in the European Parliament some MEPs unsuccessfully demanded a formal say in the process Others including Jan

Huitema (Liberals) and Anthea McIntyre (Conservatives) authored resolutions that included calls for the deregulation of new GM

techniques On 1 December 2015 a hearing took place in the European Parliament Agriculture Committee Edwin Hecker a NBT

Platform lobbyist and an employee of Schuttelaar amp Partners (although the latter was not disclosed) presented industrys views

again overstating the role of SMEs

Surprisingly only one week later the NBT Platform was deleted from Schuttelaar amp Partners list of clients in the register However

the information in the NBT Platforms entry and on its website remains unchanged (See box Does the NBT Platform still exist)

Does the NBT Platform still exist

Schuttelaar amp Partners made some remarkable changes to their registry entry on 7 December 2015 The NBT Platform has been deleted

as a client from the lobby groups entry This is contradictory as the NBT Platformrsquos entry is unchanged and still lists Mr Hecker as its

chair In line with this change the Commissions legal interpretation of Directive 200118 for the new GM techniques has been deleted

from the list of EU initiatives followed by the company

In addition the companys overall lobby-related expenses have been reduced tenfold from euro100000-500000 down to euro50000-99000

The consultancy now declares just a 08 FTE workload for lobbying activities This is at odds for instance with the fact that ten

employees currently hold lobby passes for the European Parliament

6 The Commissions interpretation Whose interests will prevail

All invested parties are now awaiting the Commissions decision to be presented in March 2016 Will the NBT Platform be

celebrating victory after achieving its Phase 4 Agreement goal Or will concerned governments NGOs and sustainable farming

67

68

69

70 71

72 73

74

75

76

77

78

79

80

organisations be relieved that the new GM technologies will be subject to the existing hard-won regulation

Maybe neither DG SANTE has already publicly stated that ldquosome will be pleased others disappointedrdquo indicating that at least

one perhaps more but not all of the new techniques will escape regulation as a result of the Commission decision If true this

would ndash no matter how many techniques are concerned ndash be a serious attack on food and environmental safety consumer choice

and transparency in the food chain as well as enhancing corporate concentration in the seed sector through patents

As Brussels itself realises the Commission release is probably just the beginning ndash and not the resolution ndash of this contentious

issue In all likelihood it will be the European Court of Justice that ultimately determines the regulatory fate of new GM

techniques The court case brought by environmental and farming organisations against Cibus ODM oilseed rape will therefore be

of great importance

In the meantime neither the biotech industry nor its financiers are likely to have the certainty they have been striving for

Furthermore other actors may still come into play Food distributors may demand direct liability for new GM products to those

who put them on the market And parliaments may insist on the labelling of new GM products like has happened in the

Netherlands The TTIP negotiations on the other hand may become a force against a proper regulation of GM 20 Environmental

and sustainable farming groups will have to remain on high alert

81

- Eckerstorfer M et al Environmental Agency Austria Technical report New plant breeding techniques and risks associated with their application 2014

httpwwwumweltbundesamtatfileadminsitepublikationenREP0477pd

- Kraumlmer L Legal questions concerning new methods for changing the genetic conditions in plants Legal analysis commissioned by Arbeitsgemeinschaft

baumluerliche Landwirtschaft (AbL) Bund fuumlr Umwelt und Naturschutz (BUND) etc September 2015

httpwwwtestbiotechorgsitesdefaultfilesKraemer_Legal20questions

- Spranger TM Legal Analysis of the applicability of Directive 200118EC on genome editing technologies Commissioned by the German Federal Agency

for Nature Conservation October 2015 httpbfndefileadminBfNagrogentechnikDokumenteLegal_analysis_of_g

Steinbrecher Ricarda Genetic Engineering in plants and the ldquoNew Breeding Techniques (NBTs)rdquo December 2015

httpwwweconexusinfopublicationgenetic-engineering-plants-and-new-

Corporate Europe Observatory and Inf OGM TTIP released emails show biotech seeds on the trade talks table 2 July 2015

httpcorporateeuropeorgfood-and-agriculture201507ttip-released-em

The Working Group was made up of two experts nominated from each member state Its final report was completed in 2012 but was never officially

published

See for a description of the techniques and reasons why they should be regulated Steinbrecher Ricarda Genetic Engineering in plants and the ldquoNew

Breeding Techniques (NBTs)rdquo December 2015 httpwwweconexusinfopublicationgenetic-engineering-plants-and-new-

Testbiotech Gene-editing and plants amp animals used in food production some technical socio-economic and legal aspects Backgrounder for Hearing on

ldquoNew Techniques for Plant Breedingrdquo in the EP Agriculture Committee 1 December 2015

httpwwwtestbiotechorgsitesdefaultfilesLegal20and20technical2

Waltz Emily Tiptoeing around Transgenics In Nature Biotechnology volume 30 number 3 March 2012

NBT Platform Fact sheet New Breeding Techniques Seizing the opportunity Version 2013

The Commission prioritised these techniques specifically since they entail ldquothe introduction of exogenous [that is lsquoforeignrsquo] genetic material into the

host which is the case for these techniques as it is for transgenesisrdquo

DG SANCO Steering note for NBT Platform meeting ldquoThe future of plant breeding techniques in the European Union 25 June 2014 Obtained through

Freedom of Information request by CEO

Several additional pieces of analysis were allocated to the Commissions Joint Research Centre (JRC)

EFSA Scientific opinion addressing the safety assessment of plants developed using cisgenesis and intragenesis 2012

httpwwwefsaeuropaeufrefsajournalpub2561

DG SANCO Background brief at the occasion of visit Mr Ladislav Miko to Keygene 26 January 2012 Obtained through Freedom of Information request

by CEO

DG SANCO Presentation on New Breeding Techniques at European Seed Association Annual Meeting 15 October 2012 Obtained through Freedom of

Information request by CEO

DG SANTE Email to NBT Platform 02 July 2015 Obtained through Freedom of Information request by CEO

European Parliament Follow up to the European Parliament resolution on ldquoPlant breeding what options to increase quality and yieldsrdquo (EP reference

number A7-00442014 P7_TA-PROV(2014)0131) 28 May 2014

BASF Letter to DEFRA 29 April 2013 Obtained through Freedom of Information request by GeneWatch

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

Finnish Board of Gene Technology Letter to Paolo Testori Coggi Director-General of DG SANCO 17 February 2014 Obtained through Freedom of

Information request by CEO

DG SANCO Letter to Finnish Board for Gene Technology 25 April 2014 Obtained through Freedom of Information request by CEO

NBT Platform two-pager April 2015 httpwwwnbtplatformorgbackground-documentsfactsheets2-pager-nbt-p

Bussink Michiel De strategie in Nederland Geen slapende honden wakker maken In Milieudefensie Magazine 1999-3

RTRS website Accessed 10 December 2015 httpwwwresponsiblesoyorgabout-rtrsgovernancetask-forcestask-for

Corporate Europe Observatory Roundtable on Responsible Soya - The certifying smokescreen 22 May 2012

httpcorporateeuropeorgsitesdefaultfilespublicationsrtrs_briefin

DG Trade Report from meeting with NBT Platform 07 June 2012 Obtained by Freedom of Information request by CEO

European Seed Association Position paper New Breeding Techniques ndash ensuring Progress and Diversity in Plant Breeding July 2012

httpswwweuroseedseusystemfilespublicationsfilesesa_1204462pdf

NBT Platform Fact sheet New Breeding Techniques Seizing the opportunity Version 2013

Cnudde F Dow Agrosciences Presentation Use of Zinc Finger Nucleases for plant breeding purposes May 2012 Obtained through Freedom of

Information request by CEO

Steinbrecher Ricarda Genetic Engineering in plants and the ldquoNew Breeding Techniques (NBTs)rdquo December 2015

httpwwweconexusinfopublicationgenetic-engineering-plants-and-new-

- httpswwwgrainorgesarticleentries588-gm-soybean-latin-america-s-

- httpslasojamatanetfilesparaguay-humanrights-reportpdf

Testbiotech Gene-editing and plants amp animals used in food production some technical socio-economic and legal aspects Backgrounder for Hearing on

ldquoNew Techniques for Plant Breedingrdquo in the EP Agriculture Committee 1 December 2015

httpwwwtestbiotechorgsitesdefaultfilesLegal20and20technical2

Fagan J Antoniou M Robinson C Earth Open Source GMO Myths and Truths 2014 httpgmomythsandtruthsearthopensourceorg

Greenpeace Twenty years of failure Why GM crops have failed to deliver on their promises November 2015

httpwwwgreenpeaceorginternationalGlobalinternationalpublication

NBT Platform two-pager April 2015 httpwwwnbtplatformorgbackground-documentsfactsheets2-pager-nbt-p

NBT Platform Email to DG Trade 18 May 2015 Obtained through Freedom of Information request by CEO Doc 2 A2D Trade

NBT Platform two-pager April 2015 httpwwwnbtplatformorgbackground-documentsfactsheets2-pager-nbt-p

EU Transparency Register Accessed 11 January 2016 httpeceuropaeutransparencyregisterpublicconsultationdisplaylobb

The lobbying activities covered by the register include all those that are ldquocarried out with the objective of directly or indirectly influencing the

formulation or implementation of policy and the decision-making processes of the EU institutions irrespective of where they are undertaken and of the

channel or medium of communication used for example via outsourcing media contracts with professional intermediaries think tanks platforms

forums campaigns and grassroots initiativesrdquo Article 7 httpeur-lexeuropaeulegal-contentENTXTHTMLuri=CELEX32014Q0919

Website NBT Platform Accessed 8 November 2015 Compared to a list provided in 2014 two members dropped off Cellectis Plant Sciences and Centre

RampD Nestleacute Tours httpwwwnbtplatformorg

DG SANCO Steering note for Mr Ladislav Miko at the occasion of a visit by Mr Hugo von Meijenfeldt Acting DG Environment Environment Ministry

Netherlands 15 November 2012

DG Trade Report from meeting with NBT Platform 07 June 2012 Obtained by Freedom of Information request by CEO

Inova Fruit is owned by five shareholders all large fruit auction companies 49 of shares are owned for instance by the Greenery that has over 1400

employees

For example Rothamsted Research website As accessed 11 January 2016 httpwwwrothamstedacuknewsnew-collaborative-research-project-gets

VIB website As accessed 21 December 2015 httpwwwvibbenlover-viborganisatiePaginasAlgemene-vergaderingaspx

ENERGYPOPLAR website As accessed 21 December 2015 httpwwwenergypoplareuinstitutionsphpid=40

NBT Platform two-pager April 2015 httpwwwnbtplatformorgbackground-documentsfactsheets2-pager-nbt-p

DG SANCO Notes of meeting with NBT Platform of 31 May 2012 06 June 2012 Obtained through Freedom of Information request by CEO

NBT Platform Proposed agenda for meeting on 22 June 2012 Obtained through Freedom of Information request by CEO

Schouten Henk Wageningen University and Research Center and Inova Fruit Presentation to European Commission Legal arguments to keep plants

from novel breeding techniques such as cisgenesis outside the GMO regulation 22 June 2012 Obtained through Freedom of Information request by CEO

Kempen F C Jung Genetic Modification of Plants Agriculture Horticulture and Forestry 2010 In Biotechnology in Agriculture and Forestry Springer

httpelibrarycomngUploadFilesfile0_10097pdf

Schuttelaar amp Partners was also hired for this project to draw up a communication plan ldquofor the acceptance and marketingrdquo of the cisgenic apple

National Academic Research and Collaborations Information System website As accessed 12 January 2016

httpwwwnarcisnlresearchRecordIDOND1310571

NBT Platform Email to DG SANCO 10 July 2012 Obtained through Freedom of Information request by CEO

17

18

19

20

21

22

23

24

25

26

27

28

29

30

31

32

33

34

35

36

37

38

39

40

41

42

43

44

45

46

47

48

49

DG Trade Report from meeting with NBT Platform 07 June 2012 Obtained through Freedom of Information request by CEO

DG Trade Report from meeting with Schuttelaar amp Partners on new breeding techniques 15 March 2012 Obtained through Freedom of Information

request by CEO

European Seed Association (ESA) Position paper Promoting and Enabling Innovation in Plant Breeding February 2014 Obtained through Freedom of

Information request by CEO

NBT Platform Legal Briefing Paper The regulatory status of plants resulting from New Breeding Technologies Version of 28 May 2013 Obtained

through Freedom of Information request by CEO

NBT Platform Summary of Legal Briefing Paper ldquoThe regulatory status of plants resulting fromNew Breeding Technologiesrdquo Obtained through Freedom

of Information request by CEO 22 May 2013 doc 512

The Directive 200118 (Annex 1B) lists two techniques ndash cell fusion and mutagenesis ndash for which an exemption has been granted and that are therefore

excluded from its scope As these two techniques predated the Directive by many years EU authorities assumed there was a lsquohistory of safe usersquo

The following documents exemplify the pro-deregulation arguments Each uses one or more of the points listed in the table

- European Technology Platform Plants for the Future Position paper New Breeding Techniques - Ensuring an Innovative and Diversified European

Agriculture September 2012 httpwwwepsoweborgfile1096

- European Seed Association Regulatory approaches to modern plant breeding - the case of mutagenesis and new gene editing technologies 20 July 2015

httpswwweuroseedseusystemfilespublicationsfilesesa_150543_0pdf

- CropLife International Position Paper Regulatory oversight of products developed through new breeding techniques 2014 httpscroplifeorgwp-

contentuploadspdf_filesRegulatory-Oversight-o

- NBT Platform Factsheet Oligonucleotide-Directed Mutagenesis accelerating innovation 2013 httpwwwnbtplatformorgbackground-

documentsfactsheetsfactsheet-oli

- NBT Platform Legal Briefing Paper The regulatory status of plants resulting from New Breeding Technologies Version of 28 May 2013

- Kraumlmer L Legal questions concerning new methods for changing the genetic conditions in plants Legal analysis commissioned by Arbeitsgemeinschaft

baumluerliche Landwirtschaft (AbL) Bund fuumlr Umwelt und Naturschutz (BUND) etc September 2015

httpwwwtestbiotechorgsitesdefaultfilesKraemer_Legal20questions

- Spranger TM Legal Analysis of the applicability of Directive 200118EC on genome editing technologies Commissioned by the German Federal Agency

for Nature Conservation October 2015 httpbfndefileadminBfNagrogentechnikDokumenteLegal_analysis_of_g

- Cotter J Zimmermann D Van Bekkem H Greenpeace Applications of the EU and Cartagena definitions of a GMO to the classification of plants

developed by cisgenesis and gene-editing techniques 2015 httpwwwgreenpeacetogreenpeacewp-contentuploads201511Applicati

- Reseau Semences Paysannes Confederation Paysanne et al Statut juridique des produits issus des nouvelles techniques de modification geacuteneacutetique des

plantes

DG SANCO Notes from meeting with NBT Platform 21 March 2014 Obtained through Freedom of Information request by CEO

NBT Platform and ETP Plants for the Future Meeting report Multilateral meeting lsquothe future of plant breeding techniques in the European Unionrsquo

Obtained through Freedom of Information request by CEO 25 June 2014

Ibid

Dow Agrosciences and DG SANCOJRC Emails April 2012 and July 2013 Obtained through Freedom of Information request by CEO

DG SANCO Internal email 8 July 2013 Obtained through Freedom of Information request by CEO

Corporate Europe Observatory and Inf OGM TTIP released emails show biotech seeds on the trade talks table 2 July 2015

httpcorporateeuropeorgfood-and-agriculture201507ttip-released-em

European Commission Letter to Competent Authorities 5 June 2015 Obtained through Freedom of Information request by CEO

Cibus Europe Letter to DG SANCO January 2015 Obtained through Freedom of Information request by CEO

Schuttelaar amp Partners Letter to Commissioner Vytenis Andriukaitis 1 December 2014 Obtained through Freedom of Information request by CEO

NBT Platform Email to Mr Ladislav Miko (DG SANTE) 26 February 2015 Obtained through Freedom of Information request by CEO

NBT Platform Email to DG Trade 18 May 2015 Obtained through Freedom of Information request by CEO

According to Agrafacts the non-paper was authored by German UK Irish and Spanish authorities

Non-paper on the regulatory status of plants generated by oligonucleotide-directed mutagenesis (ODM) 21 May 2015 Obtained through Freedom of

Information request by CEO

BVL Legal interpretation to DG SANTE 28 September 2015 Obtained through Freedom of Information request by CEO

DG SANTE Reply to Vlaams Instituut voor Biotechnologie (VIB) 9 July 2015 Obtained through Freedom of Information request by CEO (doc 24 a2d3)

Vlaams Instituut voor Biotechnologie (VIB) Letter to Mr Ladislav Miko (DG SANTE) 10 June 2015 Obtained through Freedom of Information request by

CEO

DG SANTE Reply to Vlaams Instituut voor Biotechnologie (VIB) 9 July 2015 Obtained through Freedom of Information request by CEO

Vlaams Instituut voor Biotechnologie (VIB) Email to DG SANTE 6 July 2015 Obtained through Freedom of Information request by CEO

VIB Fact series Een schimmelresistente aardappel voor Belgieuml December 2014

50

51

52

53

54

55

56

57

58

59

60

61

62

63

64

65

66

67

68

69

70

71

72

73

74

Food and agriculture

Attached files Attached files

1_briefing_visit_keygenepdf

6pdf

13_presentation_at_esa_-_15-10-2012pdf

14_briefing_visit_nl_dg_2pdf

26_letter_from_fi_registered_versionpdf

30_bto_meeting_with_nbpt-2_registered_versionpdf

34_reply_to_finland_25-4-2014_registered_versionpdf

36_nbt_platform_multilateral_meeting_25_06_2014_steering_note_registered_versionpdf

42_e-mail_dow_agro_to_jrc_-_10-4-2012pdf

431_presentation_cnudde_31-5-2012pdf

44_bto_meeting_31-5-2012pdf

45_proposed_agenda_meeting_22-6-2012pdf

462_ppt_schouten_22-6-2012pdf

51_e-mail_nbt_platform_31-5-2013pdf

511_legal_briefing_paper_-_28-5-2013pdf

512_summary_legal_paper_22-5-2013pdf

513_nbt_factsheetspdf

53_e-mail_from_dow_agro_to_sanco_2-7-2013pdf

54_internal_e-mail_dg_sanco_8-7-2013pdf

561_esa_position_paper_-_fev_2014pdf

57_invitation_to_the_meeting_on_the_future_of_plant_nbts_in_the_eu_25_06_2014pdf

nbt_platform_multilateral_meeting_ares20144089348_-_signed_version_-_third_batchpdf

9pdf

6pdf

12pdf

18pdf

17_20150610_vib_letter_redactedpdf

18_20150615_lettre_autorites_competentes_redactedpdf

21_20150702_reply_to_nbtp-redactedpdf

24_20150709_reply_to_vib_redactedpdf

27_20150722_vib_redactedpdf

28_bto_-_meeting_l_miko_with_new_breeding_technique_platform_-_27_april_2015_redactedpdf

atd_2015-5344_-_doct_2pdf

atd_2015-5344_-_doct_7pdf

atd_2015-5344_-_doct_8pdf

ares20155217184annex-ms_non_paperpdf

httpwwwvibbenleducatieDocumentsVIB_dossier_20schimmelresistent

EASAC Statement on New Breeding Techniques July 2015 httpwwweasaceufileadminPDF_sreports_statementsEasac_14_NBTpdf

EASAC Planting the Future - opportunities and challenges for using crop genetic improvement technologies for sustainable agriculture June 2013

httpwwweasaceufileadminReportsPlanting_the_FutureEASAC_Planting

However one third of the working group are also member of PRRI an industry-minded lobby group of public scientists

Corporate Europe Observatory PRRI - Are these public researchers 2008 httpcorporateeuropeorgfood-and-agriculture200806prri-are-these-p

European Parliament Committee on Agriculture Hearing on ldquoNew Techniques for Plant Breedingrdquo 1 December 2015

httpspolcmssecureeuroparleuropaeucmsdatauploadd35d2641-ab77-49

Furthermore Schuttelaar amp Partners now lists only one client (Grodan a supplier to the horticulture sector) This is in sharp contrast to the lobby firmrsquos

own website where 11 clients from the food and biotech sectors are listed as examples of ldquocurrent and recent clientsrdquo

Schuttelaar amp Partners website As accessed 13 December 2015 httpwwwschuttelaar-partnerscomclients

EU Transparency Register website As accessed 15 November 2015 (No longer in public domain available from CEO)

EU Transparency Register Accessed 16 January 2016

Dorotheacutee Andreacutee DG SANTE Comment at EP Agriculture Committee hearing 1 December 2015

75

76

77

78

79

80

81

0

14_09-28_letter_de_redactedpdf

Tag Tag

genetically modified crops

GMOs

Belgian showfield of DutchGM DuRPhpotatoes

Related Latest

REPORT

Of apples and potatoesthe Dutch lobby for thederegulation ofcisgenesisFEBRUARY 2ND 2016 THE POWER OF

LOBBIES FOOD AND AGRICULTURE

The voice of the Dutch Government has been

loud and clear in Brussels on the issue of

cisgenic plants The Dutch have waged a

sustained campaign to have new GM

techniques ndash and in particular cisgenesis ndash

excluded from EU GMO regulations Several

Dutch ministries the Dutch Parliament the

Dutch Permanent Representation in Brussels

and Dutch MEPs have energetically pursued

this goal

STORY

Canadian company railroads EUdecision-making on new GM

FEBRUARY 2ND 2016 THE POWER OF LOBBIES FOOD AND

AGRICULTURE

At least one developer of new GM crops ndash

Canadian-based Cibus ndash has attempted to

bypass the European policy process by

presenting policy makers with a fait accompli

decisions by individual Member States on the

regulatory status of new techniques as well as

prematurely-launched trials of new GM crops

STORY

EU review of weedkillerglyphosate adds secrecyto controversy

JANUARY 14TH 2016 EFSA FOOD AND AGRICULTURE

More than 80 per cent of the national experts

involved in the EUs official assessment of

glyphosate refused to have their names

disclosed to the public

STORY

Solutions COP21Climate SmartAgriculture boostingthe technofix

DECEMBER 10TH 2015 CLIMATE AND ENERGY FOOD AND

AGRICULTURE

ldquoIf you like greenwashing clap your handsrdquo

1 of 321 of 32 next rsaquo

Corporate Europe Observatory

(CEO) is a research and campaign

group working to expose and

challenge the privileged access

and influence enjoyed by

corporations and their lobby

groups in EU policy making

Read more

CEO relies on grants and

donations to carry out our

research and campaign work By

making a donation or becoming a

friend of CEO you help to

support our efforts to expose

corporate lobbying increase

transparency and urge greater

democratic accountabililty in the

EU

Or

All written content on this

website is licensed under a

Creative Commons Attribution-

NonCommercial-ShareAlike 30

Unported License

Page 3: FOROEUROPA - Biotech lobby’s push for new GMOs to escape … · 2016-02-04 · With respect to cisgenesis and intragenesis, EFSA concluded that while intragenic plants would generate

With respect to cisgenesis and intragenesis EFSA concluded that

while intragenic plants would generate similar risks to transgenic

ones cisgenic plants could be compared to conventionally bred

plants However the agency clarified that ldquoall of these breeding

methods can produce variable frequencies and severities of

unintended effects The frequency of unintended changes may

differ between breeding techniques and their occurrence cannot be

predicted and needs to be assessed case by caserdquo Furthermore

EFSA opined that ZFN-3 requires in principle the same risk

assessment that is currently applied to GMOs but that on a case-

by-case basis ldquolesser amounts of data may be neededrdquo for plants

developed using this technique

Schuttelaar amp Partners no novice to below-the-radar lobby campaigns for biotech clients

In 1995 the firm was hired by Monsanto to secure a smooth

introduction for the first imports of a GM crop ndash Monsantos

herbicide-tolerant Roundup Ready soy ndash to Europe Schuttelaar

amp Partners was set up by Marcel Schuttelaar a former campaigner

for Friends of the Earth Netherlands Familiar with Monsantos

adversaries as an insider and an outsider he was the ideal man for

the job The strategy chosen was to lsquolet sleeping dogs lie carefully

injecting tranquillising messages into the right ears in order to

avoid a sudden outcry from media and consumer organisations

The lobby firm ndash not hindered by a lack of evidence - stressed the

benefits of Roundup Ready soy such as reduced pesticide use (a

claim that has proven to be untrue)

deadline for delivering the legal guidance document In response

to the many queries from industry and member states on its

progress the standard response has been that assessing the new

techniques in the light of Directive 200118 ldquo is complex and

requires a thorough technical and legal analysisrdquo

As the Commission indicated the member states were divided

Certain EU governments including the UK the Netherlands and

Germany pressured the Commission to deregulate one or more

of the techniques The Netherlands for instance has invested

considerable public research funding in promoting the cisgenic

GMOs developed by Wageningen University and the

Commission has been pressured by Dutch Ministries the

Permanent Representation in Brussels the national parliament

and Dutch MEPs (See case study Of apples and potatoes the Dutch lobby for the deregulation of cisgenesis)

Not surprisingly corporations have been itching to get started on field trials of the new GM crops Between 2012 and 2014 BASF

and the Canadian company Cibus (among others) approached several member states including the UK Sweden and Finland to

ascertain the regulatory status of one of the techniques ndash Oligonucleotide-Directed Mutagenesis (ODM) ndash and to obtain clearance

to field trial ODM herbicide-tolerant oilseed rape without having to undergo the regulatory risk assessment required of GMOs

(See case study Canadian company railroads EU decision making on new GM)

This resulted in the Finnish government complaining to the Commission about the lack of clarity of direction on ODM leaving

the national competent authorities ldquoin a legally challenging positionrdquo since they were obliged to respond to the companies

Helsinki gave the Commission an April 2014 deadline to respond but again the Commission told them to be patient

3 New Breeding Techniques Platform corporations unite to deregulate GMOs

The trail of Freedom of Information requests over the past three years to the European Commission illuminates industrys efforts

to have new genetic engineering techniques escape regulation These efforts are coordinated by the New Breeding Techniques

(NBT) Platform whose objective is to have ldquoall NBTs ndash or as many techniques as possible ndash exempt from GM legislationrdquo The

Brussels office of Dutch lobby and public relations firm Schuttelaar amp Partners (their motto ldquoscience-based consultancy with

senserdquo) was hired to chair the NBT Platform and coordinate its lobby activities

This was perhaps not a surprising choice as company materials show that Schuttelaar amp Partnersrsquo recent clientegravele includes various

biotech industry actors whose interests are served by the NBT Platform (for example Syngenta Bayer CropScience Dow

AgroSciences biotech lobby association EuropaBio and Inova Fruit) Also the firm has not shunned highly damaging industry

campaigns in the past its first triumph was tricking decision makers into allowing Monsantos herbicide-tolerant soy to flood the

European market (See Box Schuttelaar amp Partners no novice to below-the-radar lobby campaigns for biotech clients)

Any self-respecting PR firm designing a lobbying campaign will

start off by rebranding its clients product and developing a new

lexicon to pitch it to decision makers

The NBT Platform with its very name has rebranded the new

GM techniques as new breeding techniques to make them

sound different from genetic engineering Not without success

the European Commission and other regulatory bodies have fully

adopted this term in their communication on the topic Angelika

Hilbeck senior researcher at the Swiss Federal Institute of

Technology says ldquoNew breeding techniques is a misleading

term precisely because the users of these techniques aim to

avoid any breeding They simply allow the maintenance of a

successful market variety and the improvement of an agronomic

problem that primarily arises from monoculture production

methods that promote disease and the prevalence of pests The

11

15

16

17

18

19

20

By subtly expanding the European market Schuttelaar amp Partners

helped pave the way for the further expansion of GM soy

monocultures in South America Ironically 15 years later the firm

was hired by and participated in the Round Table on Responsible

Soy (RTRS) which includes Monsanto in its membership The

RTRS is a voluntary labelling scheme that certifies GM Roundup

Ready soy as responsible although its empty criteria do nothing

to protect local communities or reduce deforestation and pesticide

use

New GM same old pitch

So why do we need a new generation of GM The NBT Platform

and other deregulation advocates echoe the arguments in favour of

introducing GM crops 20 years ago in their pitch for the new GM

techniques They invariably cite some of the key

challenges faced by society today notably ldquorapid world population

growth climate change and increasing scarcity of resources such

as soil and waterrdquo New GM techniques it is said will come to

the rescue by massively improving the precision and speed of the

plant breeding process Important objectives allegedly include pest

resistance and drought tolerance Yet the very first new GM crop in

the pipeline developed by the Canadian company Cibus is another

herbicide-tolerant oilseed rape Herbicide-tolerant GM crops have

waged social and environmental havoc in the countries where they

are mass produced Many GM 20 patent applications are related

to traits such as herbicide-tolerance insecticide production and

changed oil composition - the same as GM 10 Furthermore the

claims about the benefits of GM 10 have been refuted time and

again

products will be sold under the same familiar names except they

are now patented and ndash if industry gets its way - not labelled as

GM The techniques are non-innovative and just like GM 10

are primarily a business modelrdquo

Other labels in the new lexicon such as gene editing or

genome editing are used to emphasise surgical precision and to

suggest absolute technological control of the genetic engineering

process However as Hilbeck points out precision in changing

an organisms genetic makeup is not equivalent to safety if you

do not fully understand what you are changing and the knock-

on impacts ldquoIts like changing letters in words and words in text in a language one does not understand That can be done with

precision and control yet with complete oblivion to the meaningrdquo she says

Another key ingredient is to develop a narrative that tells how indispensable the product will be for the greater good ndash even if you

cant come up with anything new (See box New GM same old pitch)

Schuttelaar amp Partners describes the work of the NBT Platform

as providing decision makers with ldquoindependent science-based

informationrdquo on the techniques and generating awareness about

ldquotheir widespread benefitsrdquo for the European economy But

the NBT Platform is far from independent with the private

sector making up the bulk of its membership and providing most

of the funding The membership fee structure as provided on

the Platforms website lists annual subscription fees of euro7000

for Small and Medium-sized Enterprises (SMEs) euro22500 for

large companies and euro2500 for scientific institutions

However none of this is evident from the EU Transparency

Register entries of the NBT Platform and Schuttelaar amp Partners

In fact the entries of both parties exemplify the often

meaningless incomplete and incorrect information provided by

corporations and lobby firms to this register In this case the

NBT Platforms first listing in the Transparency Register is from

April 2015 at least three years after its foundation The

connection to Schuttelaar amp Partners is not mentioned and

neither the Platform members nor the funding sources are

disclosed (Also see box Transparency register generates

confusing and incorrect data on NBT Platform)

Transparency register generates confusing and incorrect data on NBT Platform

In the EU Transparency Register the NBT Platform claims that its lobby expenses total a mere euro50000-99999 per year This figure is

not very meaningful since every entity can invent its own way to calculate lobby expenses when signing up to the register As the

Platforms overall budget is not disclosed lobby costs might in fact be much larger Furthermore the NBT Platform entry reports only a

05 FTE workload dedicated to the wide range of lobby activities falling under the scope of the register Schuttelaar amp Partners Director

Edwin Hecker is named as chair of the Platform and the number of lobbyists with permanent accreditation to the European Parliament

is registered as zero However in Schuttelaar amp Partners own entry to the EU Transparency Register Hecker is mentioned as one of ten

company employees holding a permanent accreditation pass to the European Parliament

There is more information available on the NBT Platformrsquos own website but this was only launched in July 2015 The site lists the

following members Syngenta KeyGene Inova Fruit SESVanderHave Rijk Zwaan Meiogenix SweTree Technologies Semillas Fitoacute

Enza Zaden Rothamsted Research VIB (Flemish Biotechnology Institute) Fondazione Edmund Mach and the John Innes Centre

Commission documents however indicate that Dow Agrosciences and Bayer CropSciences vegetable seed business Nunhems were

21

22

23 24 25 26

27

28

29

30

31 32

33

34

35

36

also at some point members of the Platform and in any case attended NBT meetings

The NBT Platform does not let an opportunity pass to stress the interests of SMEs and research institutes in its lobby to get new

GM deregulated However taking the EU definition of a SME as a company with fewer than 250 employees only three Platform

members qualify KeyGene Meiogenix and SweTree Technologies Furthermore some of the lsquopublicrsquo research institutes that the

NBT Platform represents have strong financial ties with industry For instance Rothamsted Research (UK) has many joint projects

with agribusiness corporations And no less than one third of the general council membership of the Flemish Biotechnology

Institute (VIB) is made up of industry representatives including Syngenta and Bayer

Indeed it is important to note that both biotech SMEs and (semi-) public research institutes often play the role of technology

suppliers for big multinationals SweTree Technologies for example is engaged in the development of GM trees and claims to have

applied for 75 patents in that field Some of these products have already been licensed to BASF and SweTree Technologies claims to

collaborate with the corporation in several areas

4 Multi-phased lobby campaign against EU GMO regulation

The NBT Platformrsquos website clearly delineates the four phases of its campaign to give the death blow to GMO regulation for new

GM products

Source NBT Platform website

Following the creation of the NBT Platform in the first phase the second phase in the industryrsquos lobby campaign to the European

Commission was characterised by repeated efforts to showcase the new techniques and their claimed benefits as well as the

provision of technical and legal arguments for why they should go unregulated

In the spring of 2012 for example Schuttelaar amp Partners teamed up to chair two meetings presenting new GM techniques to staff

from DG SANCO DG Trade and DG Research and Innovation Dow presented Zinc Finger Nuclease (ZFN) technology Rijk

Zwaan introduced agroinfiltration and reverse breeding BayerNunhems explained cisgenics KeyGene made a pitch for ODM and

VIB put forward grafting on GM root stock Syngenta and Inova Fruit were also present at the meetings

In addition a legal argumentation as to why the EU should not regulate ODM and cisgenics techniques in particular was presented

by Wageningen University plant researcher Henk Schouten who was also wearing his hat as lobbyist for Inova Fruit Inova Fruit

owned by large Dutch and Flemish fruit traders contracted the private arm of Wageningen University to develop cisgenic apple

varieties Both Wageningen University and Inova Fruit clearly have commercial interests in getting cisgenesis deregulated This

shows the involvement of Wageningen University in private interest lobbying despite its public denial of this kind of activity (See

case study Of apples and potatoes the Dutch lobby for the deregulation of cisgenesis)

In May 2013 the NBT Platform presented the Commission with

37 38

39

40

41

42

43

44 45

46

47 48

Trade concerns (1) avoiding disruptions at all costs

In lobbying the Commission DG Trade was not left out In a first

meeting in March 2012 Schuttelaar amp Partners raised their clientsrsquo

concerns about ldquothe legislative uncertaintyrdquo for new GM

techniques and added that in this field ldquothe EU occupies the

second place in the world for patent applications with the UK and

the Netherlands contributing most significantlyrdquo In late May

2012 Schuttelaar amp Partners staged a second larger meeting

attended by DG SANCO DG Trade and ldquoNBT Platform membersrdquo

Dow Agrosciences VIB KeyGene Syngenta Bayer CropScience

Rothamsted Research Rijk Zwaan and Wageningen University

Their message did not fall upon deaf ears After the first meeting a

DG Trade official concluded that his DG would ldquohave to ensure

that any measuresolution proposed will not result in trade

disruptionsrdquo And furthermore he reported ldquoI was reassured by my

SANCO counterparts that the trade angle will be taken into

account when deciding on the Commissionrsquos line to takerdquo

The European Seed Association announced to DG SANCO that it

wanted new GM techniques deregulated and specifically attacked

the EU traceability and labelling requirements for their ldquopotential

to hamper free traderdquo

its piegravece de reacutesistance the industryrsquos own lsquolegal interpretationrsquo of

the regulatory status of new GM techniques This was based on

a sort of questionnaire consisting of seven main questions (and

many subquestions) that it is explained must all be answered in

the affirmative in order for a product to be regulated as a GMO

This methodology was carefully designed to ensure the desired

outcome that all of the new GM techniques in question should

be unregulated and by extension untested and unlabelled

Source NBT Platform website

Question 3 and 4 aim to twist the definition of a GMO in EU Directive 200118 which is ldquoan organism with the exception of

human beings in which the genetic material has been altered in a way that does not occur naturally by mating andor natural

recombinationrdquo Using industrys methodology most of the new techniques would escape regulation as they can provide a negative

answer to one of these two questions The Platform analysis also argues that some of the new GM techniques are simply a

variation of mutagenesis (a technique that had long been in use when Directive 200118 was developed and that was explicitly

excluded from its scope) Furthermore the industry approach aims to undermine the process-based nature of the Directive as

described earlier

The arguments put forward by the NBT Platform are at the core of industrys rationale for the deregulation of new GM These

points or variations on them can also be found in lobby documents produced by the European Seed Association (ESA) the

European Plant Science Organisation (EPSO) the pesticide lobby group Croplife International and the Flemish biotech research

institute VIB

The pro-deregulation interpretation of the scope of Europersquos GM laws has been met with wide-ranging criticism Counter-

arguments have been provided by German federal agencies (for example the opinion by Professor Tade Matthias Spranger for BfN

the German Federal Agency of Nature Conservation) a legal analysis by Professor Ludwig Kraumlmer as commissioned by German civil

society and assessments by Greenpeace farming and other environmental groups Similarly industryrsquos attempt to have new GM

49

50

51

52

53

54

55

declared safe by design and therefore exempt from regulatory risk assessment has been countered by the Austrian Environmental

Agency and various non-governmental organisations

The legal case that new GM techniques should be covered by the current regulations is in fact crystal clear

The central purpose of Directive 200118 on the deliberate release of GMOs is to protect human health and the environment from

the release of genetically modified organisms The Directive clearly provides for the advent of new GM techniques which rely upon

in vitro methods to directly modify genomes These are the very type of techniques that EU law covers with its process-based

approach (where the technique used decides if the regulations apply) That process-based regulation and the precautionary

approach that lies at the heart of the directive are justified because of the unintended and unexpected effects of both GM 10 and

GM 20 techniques Techniques that have been developed since 2001 (or that didnt have any commercial application prior to 2001)

cannot be regarded as industry argues the same as traditional mutagenesis techniques that were exempted on the grounds of a

claimed history of safe use when the EU regulations were introduced

The key arguments from industry and counter-arguments are summarised in the following table

Table Key industry arguments for the deregulation of new GM techniques

Industry argument Response

1 ldquoNew GM is just l ike traditional plant1 ldquoNew GM is just l ike traditional plant

breedingrdquobreedingrdquo

Products from new GM are just like traditionally bred

plants since ldquono foreign DNA is usedrdquo Industry seeks to

reframe the legal interpretation of a GMO in this way

because many of the new techniques do not necessarily

use DNA from another species or use genetic material

other than DNA

In EU law a GMO does not need to contain foreign DNA to qualifyIn EU law a GMO does not need to contain foreign DNA to qualify

as a GMOas a GMO

The Directive refers to ldquoan organism hellipin which genetic material has been

altered in a way that does not occur naturally by mating andor natural

recombinationrdquo The new techniques directly modify an organismrsquos genetic

material without involving mating and are therefore genetic engineering In

addition the Directive also qualifies the introduction of other types of genetic

material than DNA as GM

2 ldquoJust because a GM technique is used does2 ldquoJust because a GM technique is used does

not mean that the product is legally a GMOrdquonot mean that the product is legally a GMOrdquo

If there is no GM material present in the final product

it should not be treated as a GMO This is an attack on

the process-based (technique-based) nature of the

Directive and would mean that products of several

methods that do involve GM would be exempt

The EU has The EU has recognisedrecognised that the GM that the GM technique usedtechnique used to to changechange an an

organisms organisms does does mattermatter

Itrsquos the genetic engineering process that can lead to unintentional alterations

of the genetic material giving rise to concerns regarding food and

environmental safety These concerns remain even if the genetic engineering

agent is subsequently removed

3 ldquoGene editing techniques are a form of3 ldquoGene editing techniques are a form of

mutagenesis rdquomutagenesis rdquo

Mutagenesis is excluded from the scope of the

Directive as it was assumed to have a history of safe

use

New gene editing techniques are different and have no histor y ofNew gene editing techniques are different and have no histor y of

safe usesafe use

They are different from the mutagenesis techniques (chemical and radiation)

referred to in the Directive

4 ldquoNew GM is safe by designrdquo4 ldquoNew GM is safe by designrdquo

The claim is that the genetic interventions are precise

and targeted and therefore safe This is reflected by the

terms used gene or genome editing

New GM techniques can have multiple unintended and unexpectedNew GM techniques can have multiple unintended and unexpected

results results

New GM methods pose very similar types of risks as GM 10 and should be

regulated at minimum in the same way as existing GMOs in order to protect

the environment and public health Precision in changing the genetic makeup

of an organism does not equate safety if you do not fully understand the

impacts

5 ldquoDetection is impossiblerdquo5 ldquoDetection is impossiblerdquo

Industry claims that detection methods will not be able

Detection methods are evolving as are genetic engineeringDetection methods are evolving as are genetic engineering

techniques techniques

56 57

Trade concerns (2) TTIP kicks in

Another line of argument pursued by the NBT Platform is the

comparison of how new GM techniques are regulated ndash or not ndash in

other parts of the world cumulating in the suggestion that a

stronger level of regulation in the EU will create trade barriers

In the context of TTIP the way the US deals with the new

techniques is of particular interest For example US-based

multinational Dow informed DG SANCO in 2013 of the decision by

the US Department of Agriculture (USDA) to not regulate Dows

ZFN-1 maize The Commission later reflected however that the

US Food and Drug Administration (FDA) ldquoremains rather vaguerdquo on

the issue It should be noted that the US hardly regulates GMOs

as such There are no formal data requirements when it comes to

safety testing and biotech companies voluntarily provide whatever

information they please

Emails released by the Commission provide evidence that the (de-

)regulation of new GM techniques was indeed discussed in a March

2014 TTIP-related meeting in Washington Despite repeated claims

at the time by the Commission that ldquoGM is not on the tablerdquo US

and EU authorities sat together with seed industry lobby groups

from both sides of the Atlantic (including the European Seed

Association)

to tell the difference between a new GM and a

traditionally-bred product

While distinguishing some new GM products from non-GM products may

currently be difficult this is very likely to change in the future

6 ldquoApplication of the precautionar y principle6 ldquoApplication of the precautionar y principle

should be reconsideredrdquoshould be reconsideredrdquo

Industry claims that since there is less uncertainty

related to new gene editing techniques than with

mutagenesis using radiation or chemical mutagens and

since the precautionary principle is about uncertainty it

should not be applied to new GM techniques

Precautionar y principle should be respectedPrecautionar y principle should be respected

The precautionary principle and the process-orientated approach to risk

assessment as established under EU law can only be implemented if the new

methods are covered by the Directive

5 Last phase lobbying

The third phase of the industry campaign indicated in the graph by lsquoPoliticsPublic Affairsrsquo (read Lobby) kicked in with a so-

called multi-stakeholder meeting held on 25 June 2014 lsquoThe future of plant breeding techniques in the European Unionrsquo was a

co-production of the NBT Platform and the industry-driven European Technology Platform Plants for the Future However the

NBT Platform cast a narrow net when inviting lsquostakeholdersrsquo on its list were the Member States Competent Authorities the

Commission and companies and their lobby associations (eg the European Seed Association farming lobby Copa-Cogeca and so

forth) Absent were environmental and consumer NGOs sustainable farming organisations and the like

The industry campaign escalated during this phase with dire predictions of economic collapse and job losses following the

eventual regulation of new GM According to the NBT Platform multi-stakeholder meeting report for example industrial farming

group Copa-Cogeca said that ldquooverly strictrdquo regulation would ldquoincrease unfair competitionrdquo for farmers In turn the European Plant

Science Organisation (EPSO) insisted that the current legal uncertainty was causing ldquointelligence leakagerdquo and destroying jobs

while another participant went as far as to warn that this ambiguity would lead to the ldquocomplete extinctionrdquo of a large part of the

plant breeding sector in Europe

By the start of 2015 the Commission appeared close to reaching

a decision on new GM techniques and things were starting to

heat up

In the spring the German Government decided to take matters

into its own hands It determined that Cibus ODM oilseed rape

did not qualify as a GMO so that field trialling could proceed

with no regulation or monitoring In response the Commission

quickly sent letters to Germany and all EU member states asking

them to ldquoawait as much as possible the outcome of the

Commission legal interpretation before authorising a deliberate

release of organisms obtained with new plant breeding

techniquesrdquo since ldquothe deliberate release of products which are

subject to the rules of the EU GMO legislation without

appropriate prior authorisation is illegalrdquo (See case study

Canadian company railroads EU decision making on new GM)

But Cibus also informed the Commission that as its product was

already being grown in the US ldquothe harvested material is used

like any other crop and likely entering the international

commodity chainrdquo According to the company the possibility of

this unauthorised GM oilseed rape being imported into the EU

could therefore not be excluded

Following the May 2014 elections a new Commissioner in charge

of DG SANTE (previously called SANCO) was installed the

Lithuanian Vytenis Andriukaitis The NBT Platform set the

58

59

60

61

62

63

64

65

66

necessary liaison efforts into motion and set up a meeting that took place in July 2015 The Platform also shifted focus to liaise

and gather information from EU member states and sought a meeting with the Commission (DGs SANTE AGRI and Trade) to

report back on these contacts

Furthermore at two occasions in 2015 GM developers got assistance from certain member states that have also been peddling a

pro-deregulation agenda with Brussels In May 2015 a lsquonon-paperrsquo authored by Germany the UK Ireland and Spain argued for the

deregulation of the ODM technique in particular using the same arguments as put forth by industry to argue that ldquoODM is a

variation of mutagenesisrdquo

In September the German food safety agency BVL in a joint exercise with its UK and Irish colleagues sent an interpretation of the

definition of a GMO in Directive 200118 to the Commission This document precisely echoes the industry discourse that a

product should only be regulated under EU GMO laws if it is produced by a GM process and if the result is a product that could

not have been achieved in a lsquonaturalrsquo way

Flemish biotechnology institute (VIB) and EASAC join the chorus

In this last phase corporate-backed research institutes like the Flemish VIB also stepped up their efforts in order to defend their

commercial interests On 5 June 2015 the VIB met with the Commission to discuss a number of new techniques Although the list

has not been disclosed following freedom of information requests according to the VIB ldquo the examples given represent concrete

business opportunities and vulnerable information from the viewpoint of competitionrdquo It appears likely from the Commission response

and a related email exchange on the topic that the VIB is eyeing cisgenesis and certain gene editing techniques VIB has an obvious

commercial interest in the deregulation of cisgenesis after having put its money on turning the failed Dutch cisgenic potato into a

Belgian specialty a blight-resistant Bintje a well known potato variety widely used for the countrys famous fries

Moreover in a remarkable statement addressed to the Commission in July 2015 the European Academies Science Advisory Council

(EASAC) also backed industrys views Their political demands dovetail with those of industry GMOs should be allowed to escape

regulation ldquowhen they do not contain foreign DNArdquo that GM products should be regulated only by trait and not technique and that the

use of the precautionary principle in GM regulation should be reconsidered The statement is based on the conclusions of an earlier

EASAC report Planting the Future This report was composed by a working group of experts acting in individual capacity nominated

by member academies of EASAC

Meanwhile in the European Parliament some MEPs unsuccessfully demanded a formal say in the process Others including Jan

Huitema (Liberals) and Anthea McIntyre (Conservatives) authored resolutions that included calls for the deregulation of new GM

techniques On 1 December 2015 a hearing took place in the European Parliament Agriculture Committee Edwin Hecker a NBT

Platform lobbyist and an employee of Schuttelaar amp Partners (although the latter was not disclosed) presented industrys views

again overstating the role of SMEs

Surprisingly only one week later the NBT Platform was deleted from Schuttelaar amp Partners list of clients in the register However

the information in the NBT Platforms entry and on its website remains unchanged (See box Does the NBT Platform still exist)

Does the NBT Platform still exist

Schuttelaar amp Partners made some remarkable changes to their registry entry on 7 December 2015 The NBT Platform has been deleted

as a client from the lobby groups entry This is contradictory as the NBT Platformrsquos entry is unchanged and still lists Mr Hecker as its

chair In line with this change the Commissions legal interpretation of Directive 200118 for the new GM techniques has been deleted

from the list of EU initiatives followed by the company

In addition the companys overall lobby-related expenses have been reduced tenfold from euro100000-500000 down to euro50000-99000

The consultancy now declares just a 08 FTE workload for lobbying activities This is at odds for instance with the fact that ten

employees currently hold lobby passes for the European Parliament

6 The Commissions interpretation Whose interests will prevail

All invested parties are now awaiting the Commissions decision to be presented in March 2016 Will the NBT Platform be

celebrating victory after achieving its Phase 4 Agreement goal Or will concerned governments NGOs and sustainable farming

67

68

69

70 71

72 73

74

75

76

77

78

79

80

organisations be relieved that the new GM technologies will be subject to the existing hard-won regulation

Maybe neither DG SANTE has already publicly stated that ldquosome will be pleased others disappointedrdquo indicating that at least

one perhaps more but not all of the new techniques will escape regulation as a result of the Commission decision If true this

would ndash no matter how many techniques are concerned ndash be a serious attack on food and environmental safety consumer choice

and transparency in the food chain as well as enhancing corporate concentration in the seed sector through patents

As Brussels itself realises the Commission release is probably just the beginning ndash and not the resolution ndash of this contentious

issue In all likelihood it will be the European Court of Justice that ultimately determines the regulatory fate of new GM

techniques The court case brought by environmental and farming organisations against Cibus ODM oilseed rape will therefore be

of great importance

In the meantime neither the biotech industry nor its financiers are likely to have the certainty they have been striving for

Furthermore other actors may still come into play Food distributors may demand direct liability for new GM products to those

who put them on the market And parliaments may insist on the labelling of new GM products like has happened in the

Netherlands The TTIP negotiations on the other hand may become a force against a proper regulation of GM 20 Environmental

and sustainable farming groups will have to remain on high alert

81

- Eckerstorfer M et al Environmental Agency Austria Technical report New plant breeding techniques and risks associated with their application 2014

httpwwwumweltbundesamtatfileadminsitepublikationenREP0477pd

- Kraumlmer L Legal questions concerning new methods for changing the genetic conditions in plants Legal analysis commissioned by Arbeitsgemeinschaft

baumluerliche Landwirtschaft (AbL) Bund fuumlr Umwelt und Naturschutz (BUND) etc September 2015

httpwwwtestbiotechorgsitesdefaultfilesKraemer_Legal20questions

- Spranger TM Legal Analysis of the applicability of Directive 200118EC on genome editing technologies Commissioned by the German Federal Agency

for Nature Conservation October 2015 httpbfndefileadminBfNagrogentechnikDokumenteLegal_analysis_of_g

Steinbrecher Ricarda Genetic Engineering in plants and the ldquoNew Breeding Techniques (NBTs)rdquo December 2015

httpwwweconexusinfopublicationgenetic-engineering-plants-and-new-

Corporate Europe Observatory and Inf OGM TTIP released emails show biotech seeds on the trade talks table 2 July 2015

httpcorporateeuropeorgfood-and-agriculture201507ttip-released-em

The Working Group was made up of two experts nominated from each member state Its final report was completed in 2012 but was never officially

published

See for a description of the techniques and reasons why they should be regulated Steinbrecher Ricarda Genetic Engineering in plants and the ldquoNew

Breeding Techniques (NBTs)rdquo December 2015 httpwwweconexusinfopublicationgenetic-engineering-plants-and-new-

Testbiotech Gene-editing and plants amp animals used in food production some technical socio-economic and legal aspects Backgrounder for Hearing on

ldquoNew Techniques for Plant Breedingrdquo in the EP Agriculture Committee 1 December 2015

httpwwwtestbiotechorgsitesdefaultfilesLegal20and20technical2

Waltz Emily Tiptoeing around Transgenics In Nature Biotechnology volume 30 number 3 March 2012

NBT Platform Fact sheet New Breeding Techniques Seizing the opportunity Version 2013

The Commission prioritised these techniques specifically since they entail ldquothe introduction of exogenous [that is lsquoforeignrsquo] genetic material into the

host which is the case for these techniques as it is for transgenesisrdquo

DG SANCO Steering note for NBT Platform meeting ldquoThe future of plant breeding techniques in the European Union 25 June 2014 Obtained through

Freedom of Information request by CEO

Several additional pieces of analysis were allocated to the Commissions Joint Research Centre (JRC)

EFSA Scientific opinion addressing the safety assessment of plants developed using cisgenesis and intragenesis 2012

httpwwwefsaeuropaeufrefsajournalpub2561

DG SANCO Background brief at the occasion of visit Mr Ladislav Miko to Keygene 26 January 2012 Obtained through Freedom of Information request

by CEO

DG SANCO Presentation on New Breeding Techniques at European Seed Association Annual Meeting 15 October 2012 Obtained through Freedom of

Information request by CEO

DG SANTE Email to NBT Platform 02 July 2015 Obtained through Freedom of Information request by CEO

European Parliament Follow up to the European Parliament resolution on ldquoPlant breeding what options to increase quality and yieldsrdquo (EP reference

number A7-00442014 P7_TA-PROV(2014)0131) 28 May 2014

BASF Letter to DEFRA 29 April 2013 Obtained through Freedom of Information request by GeneWatch

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

Finnish Board of Gene Technology Letter to Paolo Testori Coggi Director-General of DG SANCO 17 February 2014 Obtained through Freedom of

Information request by CEO

DG SANCO Letter to Finnish Board for Gene Technology 25 April 2014 Obtained through Freedom of Information request by CEO

NBT Platform two-pager April 2015 httpwwwnbtplatformorgbackground-documentsfactsheets2-pager-nbt-p

Bussink Michiel De strategie in Nederland Geen slapende honden wakker maken In Milieudefensie Magazine 1999-3

RTRS website Accessed 10 December 2015 httpwwwresponsiblesoyorgabout-rtrsgovernancetask-forcestask-for

Corporate Europe Observatory Roundtable on Responsible Soya - The certifying smokescreen 22 May 2012

httpcorporateeuropeorgsitesdefaultfilespublicationsrtrs_briefin

DG Trade Report from meeting with NBT Platform 07 June 2012 Obtained by Freedom of Information request by CEO

European Seed Association Position paper New Breeding Techniques ndash ensuring Progress and Diversity in Plant Breeding July 2012

httpswwweuroseedseusystemfilespublicationsfilesesa_1204462pdf

NBT Platform Fact sheet New Breeding Techniques Seizing the opportunity Version 2013

Cnudde F Dow Agrosciences Presentation Use of Zinc Finger Nucleases for plant breeding purposes May 2012 Obtained through Freedom of

Information request by CEO

Steinbrecher Ricarda Genetic Engineering in plants and the ldquoNew Breeding Techniques (NBTs)rdquo December 2015

httpwwweconexusinfopublicationgenetic-engineering-plants-and-new-

- httpswwwgrainorgesarticleentries588-gm-soybean-latin-america-s-

- httpslasojamatanetfilesparaguay-humanrights-reportpdf

Testbiotech Gene-editing and plants amp animals used in food production some technical socio-economic and legal aspects Backgrounder for Hearing on

ldquoNew Techniques for Plant Breedingrdquo in the EP Agriculture Committee 1 December 2015

httpwwwtestbiotechorgsitesdefaultfilesLegal20and20technical2

Fagan J Antoniou M Robinson C Earth Open Source GMO Myths and Truths 2014 httpgmomythsandtruthsearthopensourceorg

Greenpeace Twenty years of failure Why GM crops have failed to deliver on their promises November 2015

httpwwwgreenpeaceorginternationalGlobalinternationalpublication

NBT Platform two-pager April 2015 httpwwwnbtplatformorgbackground-documentsfactsheets2-pager-nbt-p

NBT Platform Email to DG Trade 18 May 2015 Obtained through Freedom of Information request by CEO Doc 2 A2D Trade

NBT Platform two-pager April 2015 httpwwwnbtplatformorgbackground-documentsfactsheets2-pager-nbt-p

EU Transparency Register Accessed 11 January 2016 httpeceuropaeutransparencyregisterpublicconsultationdisplaylobb

The lobbying activities covered by the register include all those that are ldquocarried out with the objective of directly or indirectly influencing the

formulation or implementation of policy and the decision-making processes of the EU institutions irrespective of where they are undertaken and of the

channel or medium of communication used for example via outsourcing media contracts with professional intermediaries think tanks platforms

forums campaigns and grassroots initiativesrdquo Article 7 httpeur-lexeuropaeulegal-contentENTXTHTMLuri=CELEX32014Q0919

Website NBT Platform Accessed 8 November 2015 Compared to a list provided in 2014 two members dropped off Cellectis Plant Sciences and Centre

RampD Nestleacute Tours httpwwwnbtplatformorg

DG SANCO Steering note for Mr Ladislav Miko at the occasion of a visit by Mr Hugo von Meijenfeldt Acting DG Environment Environment Ministry

Netherlands 15 November 2012

DG Trade Report from meeting with NBT Platform 07 June 2012 Obtained by Freedom of Information request by CEO

Inova Fruit is owned by five shareholders all large fruit auction companies 49 of shares are owned for instance by the Greenery that has over 1400

employees

For example Rothamsted Research website As accessed 11 January 2016 httpwwwrothamstedacuknewsnew-collaborative-research-project-gets

VIB website As accessed 21 December 2015 httpwwwvibbenlover-viborganisatiePaginasAlgemene-vergaderingaspx

ENERGYPOPLAR website As accessed 21 December 2015 httpwwwenergypoplareuinstitutionsphpid=40

NBT Platform two-pager April 2015 httpwwwnbtplatformorgbackground-documentsfactsheets2-pager-nbt-p

DG SANCO Notes of meeting with NBT Platform of 31 May 2012 06 June 2012 Obtained through Freedom of Information request by CEO

NBT Platform Proposed agenda for meeting on 22 June 2012 Obtained through Freedom of Information request by CEO

Schouten Henk Wageningen University and Research Center and Inova Fruit Presentation to European Commission Legal arguments to keep plants

from novel breeding techniques such as cisgenesis outside the GMO regulation 22 June 2012 Obtained through Freedom of Information request by CEO

Kempen F C Jung Genetic Modification of Plants Agriculture Horticulture and Forestry 2010 In Biotechnology in Agriculture and Forestry Springer

httpelibrarycomngUploadFilesfile0_10097pdf

Schuttelaar amp Partners was also hired for this project to draw up a communication plan ldquofor the acceptance and marketingrdquo of the cisgenic apple

National Academic Research and Collaborations Information System website As accessed 12 January 2016

httpwwwnarcisnlresearchRecordIDOND1310571

NBT Platform Email to DG SANCO 10 July 2012 Obtained through Freedom of Information request by CEO

17

18

19

20

21

22

23

24

25

26

27

28

29

30

31

32

33

34

35

36

37

38

39

40

41

42

43

44

45

46

47

48

49

DG Trade Report from meeting with NBT Platform 07 June 2012 Obtained through Freedom of Information request by CEO

DG Trade Report from meeting with Schuttelaar amp Partners on new breeding techniques 15 March 2012 Obtained through Freedom of Information

request by CEO

European Seed Association (ESA) Position paper Promoting and Enabling Innovation in Plant Breeding February 2014 Obtained through Freedom of

Information request by CEO

NBT Platform Legal Briefing Paper The regulatory status of plants resulting from New Breeding Technologies Version of 28 May 2013 Obtained

through Freedom of Information request by CEO

NBT Platform Summary of Legal Briefing Paper ldquoThe regulatory status of plants resulting fromNew Breeding Technologiesrdquo Obtained through Freedom

of Information request by CEO 22 May 2013 doc 512

The Directive 200118 (Annex 1B) lists two techniques ndash cell fusion and mutagenesis ndash for which an exemption has been granted and that are therefore

excluded from its scope As these two techniques predated the Directive by many years EU authorities assumed there was a lsquohistory of safe usersquo

The following documents exemplify the pro-deregulation arguments Each uses one or more of the points listed in the table

- European Technology Platform Plants for the Future Position paper New Breeding Techniques - Ensuring an Innovative and Diversified European

Agriculture September 2012 httpwwwepsoweborgfile1096

- European Seed Association Regulatory approaches to modern plant breeding - the case of mutagenesis and new gene editing technologies 20 July 2015

httpswwweuroseedseusystemfilespublicationsfilesesa_150543_0pdf

- CropLife International Position Paper Regulatory oversight of products developed through new breeding techniques 2014 httpscroplifeorgwp-

contentuploadspdf_filesRegulatory-Oversight-o

- NBT Platform Factsheet Oligonucleotide-Directed Mutagenesis accelerating innovation 2013 httpwwwnbtplatformorgbackground-

documentsfactsheetsfactsheet-oli

- NBT Platform Legal Briefing Paper The regulatory status of plants resulting from New Breeding Technologies Version of 28 May 2013

- Kraumlmer L Legal questions concerning new methods for changing the genetic conditions in plants Legal analysis commissioned by Arbeitsgemeinschaft

baumluerliche Landwirtschaft (AbL) Bund fuumlr Umwelt und Naturschutz (BUND) etc September 2015

httpwwwtestbiotechorgsitesdefaultfilesKraemer_Legal20questions

- Spranger TM Legal Analysis of the applicability of Directive 200118EC on genome editing technologies Commissioned by the German Federal Agency

for Nature Conservation October 2015 httpbfndefileadminBfNagrogentechnikDokumenteLegal_analysis_of_g

- Cotter J Zimmermann D Van Bekkem H Greenpeace Applications of the EU and Cartagena definitions of a GMO to the classification of plants

developed by cisgenesis and gene-editing techniques 2015 httpwwwgreenpeacetogreenpeacewp-contentuploads201511Applicati

- Reseau Semences Paysannes Confederation Paysanne et al Statut juridique des produits issus des nouvelles techniques de modification geacuteneacutetique des

plantes

DG SANCO Notes from meeting with NBT Platform 21 March 2014 Obtained through Freedom of Information request by CEO

NBT Platform and ETP Plants for the Future Meeting report Multilateral meeting lsquothe future of plant breeding techniques in the European Unionrsquo

Obtained through Freedom of Information request by CEO 25 June 2014

Ibid

Dow Agrosciences and DG SANCOJRC Emails April 2012 and July 2013 Obtained through Freedom of Information request by CEO

DG SANCO Internal email 8 July 2013 Obtained through Freedom of Information request by CEO

Corporate Europe Observatory and Inf OGM TTIP released emails show biotech seeds on the trade talks table 2 July 2015

httpcorporateeuropeorgfood-and-agriculture201507ttip-released-em

European Commission Letter to Competent Authorities 5 June 2015 Obtained through Freedom of Information request by CEO

Cibus Europe Letter to DG SANCO January 2015 Obtained through Freedom of Information request by CEO

Schuttelaar amp Partners Letter to Commissioner Vytenis Andriukaitis 1 December 2014 Obtained through Freedom of Information request by CEO

NBT Platform Email to Mr Ladislav Miko (DG SANTE) 26 February 2015 Obtained through Freedom of Information request by CEO

NBT Platform Email to DG Trade 18 May 2015 Obtained through Freedom of Information request by CEO

According to Agrafacts the non-paper was authored by German UK Irish and Spanish authorities

Non-paper on the regulatory status of plants generated by oligonucleotide-directed mutagenesis (ODM) 21 May 2015 Obtained through Freedom of

Information request by CEO

BVL Legal interpretation to DG SANTE 28 September 2015 Obtained through Freedom of Information request by CEO

DG SANTE Reply to Vlaams Instituut voor Biotechnologie (VIB) 9 July 2015 Obtained through Freedom of Information request by CEO (doc 24 a2d3)

Vlaams Instituut voor Biotechnologie (VIB) Letter to Mr Ladislav Miko (DG SANTE) 10 June 2015 Obtained through Freedom of Information request by

CEO

DG SANTE Reply to Vlaams Instituut voor Biotechnologie (VIB) 9 July 2015 Obtained through Freedom of Information request by CEO

Vlaams Instituut voor Biotechnologie (VIB) Email to DG SANTE 6 July 2015 Obtained through Freedom of Information request by CEO

VIB Fact series Een schimmelresistente aardappel voor Belgieuml December 2014

50

51

52

53

54

55

56

57

58

59

60

61

62

63

64

65

66

67

68

69

70

71

72

73

74

Food and agriculture

Attached files Attached files

1_briefing_visit_keygenepdf

6pdf

13_presentation_at_esa_-_15-10-2012pdf

14_briefing_visit_nl_dg_2pdf

26_letter_from_fi_registered_versionpdf

30_bto_meeting_with_nbpt-2_registered_versionpdf

34_reply_to_finland_25-4-2014_registered_versionpdf

36_nbt_platform_multilateral_meeting_25_06_2014_steering_note_registered_versionpdf

42_e-mail_dow_agro_to_jrc_-_10-4-2012pdf

431_presentation_cnudde_31-5-2012pdf

44_bto_meeting_31-5-2012pdf

45_proposed_agenda_meeting_22-6-2012pdf

462_ppt_schouten_22-6-2012pdf

51_e-mail_nbt_platform_31-5-2013pdf

511_legal_briefing_paper_-_28-5-2013pdf

512_summary_legal_paper_22-5-2013pdf

513_nbt_factsheetspdf

53_e-mail_from_dow_agro_to_sanco_2-7-2013pdf

54_internal_e-mail_dg_sanco_8-7-2013pdf

561_esa_position_paper_-_fev_2014pdf

57_invitation_to_the_meeting_on_the_future_of_plant_nbts_in_the_eu_25_06_2014pdf

nbt_platform_multilateral_meeting_ares20144089348_-_signed_version_-_third_batchpdf

9pdf

6pdf

12pdf

18pdf

17_20150610_vib_letter_redactedpdf

18_20150615_lettre_autorites_competentes_redactedpdf

21_20150702_reply_to_nbtp-redactedpdf

24_20150709_reply_to_vib_redactedpdf

27_20150722_vib_redactedpdf

28_bto_-_meeting_l_miko_with_new_breeding_technique_platform_-_27_april_2015_redactedpdf

atd_2015-5344_-_doct_2pdf

atd_2015-5344_-_doct_7pdf

atd_2015-5344_-_doct_8pdf

ares20155217184annex-ms_non_paperpdf

httpwwwvibbenleducatieDocumentsVIB_dossier_20schimmelresistent

EASAC Statement on New Breeding Techniques July 2015 httpwwweasaceufileadminPDF_sreports_statementsEasac_14_NBTpdf

EASAC Planting the Future - opportunities and challenges for using crop genetic improvement technologies for sustainable agriculture June 2013

httpwwweasaceufileadminReportsPlanting_the_FutureEASAC_Planting

However one third of the working group are also member of PRRI an industry-minded lobby group of public scientists

Corporate Europe Observatory PRRI - Are these public researchers 2008 httpcorporateeuropeorgfood-and-agriculture200806prri-are-these-p

European Parliament Committee on Agriculture Hearing on ldquoNew Techniques for Plant Breedingrdquo 1 December 2015

httpspolcmssecureeuroparleuropaeucmsdatauploadd35d2641-ab77-49

Furthermore Schuttelaar amp Partners now lists only one client (Grodan a supplier to the horticulture sector) This is in sharp contrast to the lobby firmrsquos

own website where 11 clients from the food and biotech sectors are listed as examples of ldquocurrent and recent clientsrdquo

Schuttelaar amp Partners website As accessed 13 December 2015 httpwwwschuttelaar-partnerscomclients

EU Transparency Register website As accessed 15 November 2015 (No longer in public domain available from CEO)

EU Transparency Register Accessed 16 January 2016

Dorotheacutee Andreacutee DG SANTE Comment at EP Agriculture Committee hearing 1 December 2015

75

76

77

78

79

80

81

0

14_09-28_letter_de_redactedpdf

Tag Tag

genetically modified crops

GMOs

Belgian showfield of DutchGM DuRPhpotatoes

Related Latest

REPORT

Of apples and potatoesthe Dutch lobby for thederegulation ofcisgenesisFEBRUARY 2ND 2016 THE POWER OF

LOBBIES FOOD AND AGRICULTURE

The voice of the Dutch Government has been

loud and clear in Brussels on the issue of

cisgenic plants The Dutch have waged a

sustained campaign to have new GM

techniques ndash and in particular cisgenesis ndash

excluded from EU GMO regulations Several

Dutch ministries the Dutch Parliament the

Dutch Permanent Representation in Brussels

and Dutch MEPs have energetically pursued

this goal

STORY

Canadian company railroads EUdecision-making on new GM

FEBRUARY 2ND 2016 THE POWER OF LOBBIES FOOD AND

AGRICULTURE

At least one developer of new GM crops ndash

Canadian-based Cibus ndash has attempted to

bypass the European policy process by

presenting policy makers with a fait accompli

decisions by individual Member States on the

regulatory status of new techniques as well as

prematurely-launched trials of new GM crops

STORY

EU review of weedkillerglyphosate adds secrecyto controversy

JANUARY 14TH 2016 EFSA FOOD AND AGRICULTURE

More than 80 per cent of the national experts

involved in the EUs official assessment of

glyphosate refused to have their names

disclosed to the public

STORY

Solutions COP21Climate SmartAgriculture boostingthe technofix

DECEMBER 10TH 2015 CLIMATE AND ENERGY FOOD AND

AGRICULTURE

ldquoIf you like greenwashing clap your handsrdquo

1 of 321 of 32 next rsaquo

Corporate Europe Observatory

(CEO) is a research and campaign

group working to expose and

challenge the privileged access

and influence enjoyed by

corporations and their lobby

groups in EU policy making

Read more

CEO relies on grants and

donations to carry out our

research and campaign work By

making a donation or becoming a

friend of CEO you help to

support our efforts to expose

corporate lobbying increase

transparency and urge greater

democratic accountabililty in the

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Or

All written content on this

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Creative Commons Attribution-

NonCommercial-ShareAlike 30

Unported License

Page 4: FOROEUROPA - Biotech lobby’s push for new GMOs to escape … · 2016-02-04 · With respect to cisgenesis and intragenesis, EFSA concluded that while intragenic plants would generate

By subtly expanding the European market Schuttelaar amp Partners

helped pave the way for the further expansion of GM soy

monocultures in South America Ironically 15 years later the firm

was hired by and participated in the Round Table on Responsible

Soy (RTRS) which includes Monsanto in its membership The

RTRS is a voluntary labelling scheme that certifies GM Roundup

Ready soy as responsible although its empty criteria do nothing

to protect local communities or reduce deforestation and pesticide

use

New GM same old pitch

So why do we need a new generation of GM The NBT Platform

and other deregulation advocates echoe the arguments in favour of

introducing GM crops 20 years ago in their pitch for the new GM

techniques They invariably cite some of the key

challenges faced by society today notably ldquorapid world population

growth climate change and increasing scarcity of resources such

as soil and waterrdquo New GM techniques it is said will come to

the rescue by massively improving the precision and speed of the

plant breeding process Important objectives allegedly include pest

resistance and drought tolerance Yet the very first new GM crop in

the pipeline developed by the Canadian company Cibus is another

herbicide-tolerant oilseed rape Herbicide-tolerant GM crops have

waged social and environmental havoc in the countries where they

are mass produced Many GM 20 patent applications are related

to traits such as herbicide-tolerance insecticide production and

changed oil composition - the same as GM 10 Furthermore the

claims about the benefits of GM 10 have been refuted time and

again

products will be sold under the same familiar names except they

are now patented and ndash if industry gets its way - not labelled as

GM The techniques are non-innovative and just like GM 10

are primarily a business modelrdquo

Other labels in the new lexicon such as gene editing or

genome editing are used to emphasise surgical precision and to

suggest absolute technological control of the genetic engineering

process However as Hilbeck points out precision in changing

an organisms genetic makeup is not equivalent to safety if you

do not fully understand what you are changing and the knock-

on impacts ldquoIts like changing letters in words and words in text in a language one does not understand That can be done with

precision and control yet with complete oblivion to the meaningrdquo she says

Another key ingredient is to develop a narrative that tells how indispensable the product will be for the greater good ndash even if you

cant come up with anything new (See box New GM same old pitch)

Schuttelaar amp Partners describes the work of the NBT Platform

as providing decision makers with ldquoindependent science-based

informationrdquo on the techniques and generating awareness about

ldquotheir widespread benefitsrdquo for the European economy But

the NBT Platform is far from independent with the private

sector making up the bulk of its membership and providing most

of the funding The membership fee structure as provided on

the Platforms website lists annual subscription fees of euro7000

for Small and Medium-sized Enterprises (SMEs) euro22500 for

large companies and euro2500 for scientific institutions

However none of this is evident from the EU Transparency

Register entries of the NBT Platform and Schuttelaar amp Partners

In fact the entries of both parties exemplify the often

meaningless incomplete and incorrect information provided by

corporations and lobby firms to this register In this case the

NBT Platforms first listing in the Transparency Register is from

April 2015 at least three years after its foundation The

connection to Schuttelaar amp Partners is not mentioned and

neither the Platform members nor the funding sources are

disclosed (Also see box Transparency register generates

confusing and incorrect data on NBT Platform)

Transparency register generates confusing and incorrect data on NBT Platform

In the EU Transparency Register the NBT Platform claims that its lobby expenses total a mere euro50000-99999 per year This figure is

not very meaningful since every entity can invent its own way to calculate lobby expenses when signing up to the register As the

Platforms overall budget is not disclosed lobby costs might in fact be much larger Furthermore the NBT Platform entry reports only a

05 FTE workload dedicated to the wide range of lobby activities falling under the scope of the register Schuttelaar amp Partners Director

Edwin Hecker is named as chair of the Platform and the number of lobbyists with permanent accreditation to the European Parliament

is registered as zero However in Schuttelaar amp Partners own entry to the EU Transparency Register Hecker is mentioned as one of ten

company employees holding a permanent accreditation pass to the European Parliament

There is more information available on the NBT Platformrsquos own website but this was only launched in July 2015 The site lists the

following members Syngenta KeyGene Inova Fruit SESVanderHave Rijk Zwaan Meiogenix SweTree Technologies Semillas Fitoacute

Enza Zaden Rothamsted Research VIB (Flemish Biotechnology Institute) Fondazione Edmund Mach and the John Innes Centre

Commission documents however indicate that Dow Agrosciences and Bayer CropSciences vegetable seed business Nunhems were

21

22

23 24 25 26

27

28

29

30

31 32

33

34

35

36

also at some point members of the Platform and in any case attended NBT meetings

The NBT Platform does not let an opportunity pass to stress the interests of SMEs and research institutes in its lobby to get new

GM deregulated However taking the EU definition of a SME as a company with fewer than 250 employees only three Platform

members qualify KeyGene Meiogenix and SweTree Technologies Furthermore some of the lsquopublicrsquo research institutes that the

NBT Platform represents have strong financial ties with industry For instance Rothamsted Research (UK) has many joint projects

with agribusiness corporations And no less than one third of the general council membership of the Flemish Biotechnology

Institute (VIB) is made up of industry representatives including Syngenta and Bayer

Indeed it is important to note that both biotech SMEs and (semi-) public research institutes often play the role of technology

suppliers for big multinationals SweTree Technologies for example is engaged in the development of GM trees and claims to have

applied for 75 patents in that field Some of these products have already been licensed to BASF and SweTree Technologies claims to

collaborate with the corporation in several areas

4 Multi-phased lobby campaign against EU GMO regulation

The NBT Platformrsquos website clearly delineates the four phases of its campaign to give the death blow to GMO regulation for new

GM products

Source NBT Platform website

Following the creation of the NBT Platform in the first phase the second phase in the industryrsquos lobby campaign to the European

Commission was characterised by repeated efforts to showcase the new techniques and their claimed benefits as well as the

provision of technical and legal arguments for why they should go unregulated

In the spring of 2012 for example Schuttelaar amp Partners teamed up to chair two meetings presenting new GM techniques to staff

from DG SANCO DG Trade and DG Research and Innovation Dow presented Zinc Finger Nuclease (ZFN) technology Rijk

Zwaan introduced agroinfiltration and reverse breeding BayerNunhems explained cisgenics KeyGene made a pitch for ODM and

VIB put forward grafting on GM root stock Syngenta and Inova Fruit were also present at the meetings

In addition a legal argumentation as to why the EU should not regulate ODM and cisgenics techniques in particular was presented

by Wageningen University plant researcher Henk Schouten who was also wearing his hat as lobbyist for Inova Fruit Inova Fruit

owned by large Dutch and Flemish fruit traders contracted the private arm of Wageningen University to develop cisgenic apple

varieties Both Wageningen University and Inova Fruit clearly have commercial interests in getting cisgenesis deregulated This

shows the involvement of Wageningen University in private interest lobbying despite its public denial of this kind of activity (See

case study Of apples and potatoes the Dutch lobby for the deregulation of cisgenesis)

In May 2013 the NBT Platform presented the Commission with

37 38

39

40

41

42

43

44 45

46

47 48

Trade concerns (1) avoiding disruptions at all costs

In lobbying the Commission DG Trade was not left out In a first

meeting in March 2012 Schuttelaar amp Partners raised their clientsrsquo

concerns about ldquothe legislative uncertaintyrdquo for new GM

techniques and added that in this field ldquothe EU occupies the

second place in the world for patent applications with the UK and

the Netherlands contributing most significantlyrdquo In late May

2012 Schuttelaar amp Partners staged a second larger meeting

attended by DG SANCO DG Trade and ldquoNBT Platform membersrdquo

Dow Agrosciences VIB KeyGene Syngenta Bayer CropScience

Rothamsted Research Rijk Zwaan and Wageningen University

Their message did not fall upon deaf ears After the first meeting a

DG Trade official concluded that his DG would ldquohave to ensure

that any measuresolution proposed will not result in trade

disruptionsrdquo And furthermore he reported ldquoI was reassured by my

SANCO counterparts that the trade angle will be taken into

account when deciding on the Commissionrsquos line to takerdquo

The European Seed Association announced to DG SANCO that it

wanted new GM techniques deregulated and specifically attacked

the EU traceability and labelling requirements for their ldquopotential

to hamper free traderdquo

its piegravece de reacutesistance the industryrsquos own lsquolegal interpretationrsquo of

the regulatory status of new GM techniques This was based on

a sort of questionnaire consisting of seven main questions (and

many subquestions) that it is explained must all be answered in

the affirmative in order for a product to be regulated as a GMO

This methodology was carefully designed to ensure the desired

outcome that all of the new GM techniques in question should

be unregulated and by extension untested and unlabelled

Source NBT Platform website

Question 3 and 4 aim to twist the definition of a GMO in EU Directive 200118 which is ldquoan organism with the exception of

human beings in which the genetic material has been altered in a way that does not occur naturally by mating andor natural

recombinationrdquo Using industrys methodology most of the new techniques would escape regulation as they can provide a negative

answer to one of these two questions The Platform analysis also argues that some of the new GM techniques are simply a

variation of mutagenesis (a technique that had long been in use when Directive 200118 was developed and that was explicitly

excluded from its scope) Furthermore the industry approach aims to undermine the process-based nature of the Directive as

described earlier

The arguments put forward by the NBT Platform are at the core of industrys rationale for the deregulation of new GM These

points or variations on them can also be found in lobby documents produced by the European Seed Association (ESA) the

European Plant Science Organisation (EPSO) the pesticide lobby group Croplife International and the Flemish biotech research

institute VIB

The pro-deregulation interpretation of the scope of Europersquos GM laws has been met with wide-ranging criticism Counter-

arguments have been provided by German federal agencies (for example the opinion by Professor Tade Matthias Spranger for BfN

the German Federal Agency of Nature Conservation) a legal analysis by Professor Ludwig Kraumlmer as commissioned by German civil

society and assessments by Greenpeace farming and other environmental groups Similarly industryrsquos attempt to have new GM

49

50

51

52

53

54

55

declared safe by design and therefore exempt from regulatory risk assessment has been countered by the Austrian Environmental

Agency and various non-governmental organisations

The legal case that new GM techniques should be covered by the current regulations is in fact crystal clear

The central purpose of Directive 200118 on the deliberate release of GMOs is to protect human health and the environment from

the release of genetically modified organisms The Directive clearly provides for the advent of new GM techniques which rely upon

in vitro methods to directly modify genomes These are the very type of techniques that EU law covers with its process-based

approach (where the technique used decides if the regulations apply) That process-based regulation and the precautionary

approach that lies at the heart of the directive are justified because of the unintended and unexpected effects of both GM 10 and

GM 20 techniques Techniques that have been developed since 2001 (or that didnt have any commercial application prior to 2001)

cannot be regarded as industry argues the same as traditional mutagenesis techniques that were exempted on the grounds of a

claimed history of safe use when the EU regulations were introduced

The key arguments from industry and counter-arguments are summarised in the following table

Table Key industry arguments for the deregulation of new GM techniques

Industry argument Response

1 ldquoNew GM is just l ike traditional plant1 ldquoNew GM is just l ike traditional plant

breedingrdquobreedingrdquo

Products from new GM are just like traditionally bred

plants since ldquono foreign DNA is usedrdquo Industry seeks to

reframe the legal interpretation of a GMO in this way

because many of the new techniques do not necessarily

use DNA from another species or use genetic material

other than DNA

In EU law a GMO does not need to contain foreign DNA to qualifyIn EU law a GMO does not need to contain foreign DNA to qualify

as a GMOas a GMO

The Directive refers to ldquoan organism hellipin which genetic material has been

altered in a way that does not occur naturally by mating andor natural

recombinationrdquo The new techniques directly modify an organismrsquos genetic

material without involving mating and are therefore genetic engineering In

addition the Directive also qualifies the introduction of other types of genetic

material than DNA as GM

2 ldquoJust because a GM technique is used does2 ldquoJust because a GM technique is used does

not mean that the product is legally a GMOrdquonot mean that the product is legally a GMOrdquo

If there is no GM material present in the final product

it should not be treated as a GMO This is an attack on

the process-based (technique-based) nature of the

Directive and would mean that products of several

methods that do involve GM would be exempt

The EU has The EU has recognisedrecognised that the GM that the GM technique usedtechnique used to to changechange an an

organisms organisms does does mattermatter

Itrsquos the genetic engineering process that can lead to unintentional alterations

of the genetic material giving rise to concerns regarding food and

environmental safety These concerns remain even if the genetic engineering

agent is subsequently removed

3 ldquoGene editing techniques are a form of3 ldquoGene editing techniques are a form of

mutagenesis rdquomutagenesis rdquo

Mutagenesis is excluded from the scope of the

Directive as it was assumed to have a history of safe

use

New gene editing techniques are different and have no histor y ofNew gene editing techniques are different and have no histor y of

safe usesafe use

They are different from the mutagenesis techniques (chemical and radiation)

referred to in the Directive

4 ldquoNew GM is safe by designrdquo4 ldquoNew GM is safe by designrdquo

The claim is that the genetic interventions are precise

and targeted and therefore safe This is reflected by the

terms used gene or genome editing

New GM techniques can have multiple unintended and unexpectedNew GM techniques can have multiple unintended and unexpected

results results

New GM methods pose very similar types of risks as GM 10 and should be

regulated at minimum in the same way as existing GMOs in order to protect

the environment and public health Precision in changing the genetic makeup

of an organism does not equate safety if you do not fully understand the

impacts

5 ldquoDetection is impossiblerdquo5 ldquoDetection is impossiblerdquo

Industry claims that detection methods will not be able

Detection methods are evolving as are genetic engineeringDetection methods are evolving as are genetic engineering

techniques techniques

56 57

Trade concerns (2) TTIP kicks in

Another line of argument pursued by the NBT Platform is the

comparison of how new GM techniques are regulated ndash or not ndash in

other parts of the world cumulating in the suggestion that a

stronger level of regulation in the EU will create trade barriers

In the context of TTIP the way the US deals with the new

techniques is of particular interest For example US-based

multinational Dow informed DG SANCO in 2013 of the decision by

the US Department of Agriculture (USDA) to not regulate Dows

ZFN-1 maize The Commission later reflected however that the

US Food and Drug Administration (FDA) ldquoremains rather vaguerdquo on

the issue It should be noted that the US hardly regulates GMOs

as such There are no formal data requirements when it comes to

safety testing and biotech companies voluntarily provide whatever

information they please

Emails released by the Commission provide evidence that the (de-

)regulation of new GM techniques was indeed discussed in a March

2014 TTIP-related meeting in Washington Despite repeated claims

at the time by the Commission that ldquoGM is not on the tablerdquo US

and EU authorities sat together with seed industry lobby groups

from both sides of the Atlantic (including the European Seed

Association)

to tell the difference between a new GM and a

traditionally-bred product

While distinguishing some new GM products from non-GM products may

currently be difficult this is very likely to change in the future

6 ldquoApplication of the precautionar y principle6 ldquoApplication of the precautionar y principle

should be reconsideredrdquoshould be reconsideredrdquo

Industry claims that since there is less uncertainty

related to new gene editing techniques than with

mutagenesis using radiation or chemical mutagens and

since the precautionary principle is about uncertainty it

should not be applied to new GM techniques

Precautionar y principle should be respectedPrecautionar y principle should be respected

The precautionary principle and the process-orientated approach to risk

assessment as established under EU law can only be implemented if the new

methods are covered by the Directive

5 Last phase lobbying

The third phase of the industry campaign indicated in the graph by lsquoPoliticsPublic Affairsrsquo (read Lobby) kicked in with a so-

called multi-stakeholder meeting held on 25 June 2014 lsquoThe future of plant breeding techniques in the European Unionrsquo was a

co-production of the NBT Platform and the industry-driven European Technology Platform Plants for the Future However the

NBT Platform cast a narrow net when inviting lsquostakeholdersrsquo on its list were the Member States Competent Authorities the

Commission and companies and their lobby associations (eg the European Seed Association farming lobby Copa-Cogeca and so

forth) Absent were environmental and consumer NGOs sustainable farming organisations and the like

The industry campaign escalated during this phase with dire predictions of economic collapse and job losses following the

eventual regulation of new GM According to the NBT Platform multi-stakeholder meeting report for example industrial farming

group Copa-Cogeca said that ldquooverly strictrdquo regulation would ldquoincrease unfair competitionrdquo for farmers In turn the European Plant

Science Organisation (EPSO) insisted that the current legal uncertainty was causing ldquointelligence leakagerdquo and destroying jobs

while another participant went as far as to warn that this ambiguity would lead to the ldquocomplete extinctionrdquo of a large part of the

plant breeding sector in Europe

By the start of 2015 the Commission appeared close to reaching

a decision on new GM techniques and things were starting to

heat up

In the spring the German Government decided to take matters

into its own hands It determined that Cibus ODM oilseed rape

did not qualify as a GMO so that field trialling could proceed

with no regulation or monitoring In response the Commission

quickly sent letters to Germany and all EU member states asking

them to ldquoawait as much as possible the outcome of the

Commission legal interpretation before authorising a deliberate

release of organisms obtained with new plant breeding

techniquesrdquo since ldquothe deliberate release of products which are

subject to the rules of the EU GMO legislation without

appropriate prior authorisation is illegalrdquo (See case study

Canadian company railroads EU decision making on new GM)

But Cibus also informed the Commission that as its product was

already being grown in the US ldquothe harvested material is used

like any other crop and likely entering the international

commodity chainrdquo According to the company the possibility of

this unauthorised GM oilseed rape being imported into the EU

could therefore not be excluded

Following the May 2014 elections a new Commissioner in charge

of DG SANTE (previously called SANCO) was installed the

Lithuanian Vytenis Andriukaitis The NBT Platform set the

58

59

60

61

62

63

64

65

66

necessary liaison efforts into motion and set up a meeting that took place in July 2015 The Platform also shifted focus to liaise

and gather information from EU member states and sought a meeting with the Commission (DGs SANTE AGRI and Trade) to

report back on these contacts

Furthermore at two occasions in 2015 GM developers got assistance from certain member states that have also been peddling a

pro-deregulation agenda with Brussels In May 2015 a lsquonon-paperrsquo authored by Germany the UK Ireland and Spain argued for the

deregulation of the ODM technique in particular using the same arguments as put forth by industry to argue that ldquoODM is a

variation of mutagenesisrdquo

In September the German food safety agency BVL in a joint exercise with its UK and Irish colleagues sent an interpretation of the

definition of a GMO in Directive 200118 to the Commission This document precisely echoes the industry discourse that a

product should only be regulated under EU GMO laws if it is produced by a GM process and if the result is a product that could

not have been achieved in a lsquonaturalrsquo way

Flemish biotechnology institute (VIB) and EASAC join the chorus

In this last phase corporate-backed research institutes like the Flemish VIB also stepped up their efforts in order to defend their

commercial interests On 5 June 2015 the VIB met with the Commission to discuss a number of new techniques Although the list

has not been disclosed following freedom of information requests according to the VIB ldquo the examples given represent concrete

business opportunities and vulnerable information from the viewpoint of competitionrdquo It appears likely from the Commission response

and a related email exchange on the topic that the VIB is eyeing cisgenesis and certain gene editing techniques VIB has an obvious

commercial interest in the deregulation of cisgenesis after having put its money on turning the failed Dutch cisgenic potato into a

Belgian specialty a blight-resistant Bintje a well known potato variety widely used for the countrys famous fries

Moreover in a remarkable statement addressed to the Commission in July 2015 the European Academies Science Advisory Council

(EASAC) also backed industrys views Their political demands dovetail with those of industry GMOs should be allowed to escape

regulation ldquowhen they do not contain foreign DNArdquo that GM products should be regulated only by trait and not technique and that the

use of the precautionary principle in GM regulation should be reconsidered The statement is based on the conclusions of an earlier

EASAC report Planting the Future This report was composed by a working group of experts acting in individual capacity nominated

by member academies of EASAC

Meanwhile in the European Parliament some MEPs unsuccessfully demanded a formal say in the process Others including Jan

Huitema (Liberals) and Anthea McIntyre (Conservatives) authored resolutions that included calls for the deregulation of new GM

techniques On 1 December 2015 a hearing took place in the European Parliament Agriculture Committee Edwin Hecker a NBT

Platform lobbyist and an employee of Schuttelaar amp Partners (although the latter was not disclosed) presented industrys views

again overstating the role of SMEs

Surprisingly only one week later the NBT Platform was deleted from Schuttelaar amp Partners list of clients in the register However

the information in the NBT Platforms entry and on its website remains unchanged (See box Does the NBT Platform still exist)

Does the NBT Platform still exist

Schuttelaar amp Partners made some remarkable changes to their registry entry on 7 December 2015 The NBT Platform has been deleted

as a client from the lobby groups entry This is contradictory as the NBT Platformrsquos entry is unchanged and still lists Mr Hecker as its

chair In line with this change the Commissions legal interpretation of Directive 200118 for the new GM techniques has been deleted

from the list of EU initiatives followed by the company

In addition the companys overall lobby-related expenses have been reduced tenfold from euro100000-500000 down to euro50000-99000

The consultancy now declares just a 08 FTE workload for lobbying activities This is at odds for instance with the fact that ten

employees currently hold lobby passes for the European Parliament

6 The Commissions interpretation Whose interests will prevail

All invested parties are now awaiting the Commissions decision to be presented in March 2016 Will the NBT Platform be

celebrating victory after achieving its Phase 4 Agreement goal Or will concerned governments NGOs and sustainable farming

67

68

69

70 71

72 73

74

75

76

77

78

79

80

organisations be relieved that the new GM technologies will be subject to the existing hard-won regulation

Maybe neither DG SANTE has already publicly stated that ldquosome will be pleased others disappointedrdquo indicating that at least

one perhaps more but not all of the new techniques will escape regulation as a result of the Commission decision If true this

would ndash no matter how many techniques are concerned ndash be a serious attack on food and environmental safety consumer choice

and transparency in the food chain as well as enhancing corporate concentration in the seed sector through patents

As Brussels itself realises the Commission release is probably just the beginning ndash and not the resolution ndash of this contentious

issue In all likelihood it will be the European Court of Justice that ultimately determines the regulatory fate of new GM

techniques The court case brought by environmental and farming organisations against Cibus ODM oilseed rape will therefore be

of great importance

In the meantime neither the biotech industry nor its financiers are likely to have the certainty they have been striving for

Furthermore other actors may still come into play Food distributors may demand direct liability for new GM products to those

who put them on the market And parliaments may insist on the labelling of new GM products like has happened in the

Netherlands The TTIP negotiations on the other hand may become a force against a proper regulation of GM 20 Environmental

and sustainable farming groups will have to remain on high alert

81

- Eckerstorfer M et al Environmental Agency Austria Technical report New plant breeding techniques and risks associated with their application 2014

httpwwwumweltbundesamtatfileadminsitepublikationenREP0477pd

- Kraumlmer L Legal questions concerning new methods for changing the genetic conditions in plants Legal analysis commissioned by Arbeitsgemeinschaft

baumluerliche Landwirtschaft (AbL) Bund fuumlr Umwelt und Naturschutz (BUND) etc September 2015

httpwwwtestbiotechorgsitesdefaultfilesKraemer_Legal20questions

- Spranger TM Legal Analysis of the applicability of Directive 200118EC on genome editing technologies Commissioned by the German Federal Agency

for Nature Conservation October 2015 httpbfndefileadminBfNagrogentechnikDokumenteLegal_analysis_of_g

Steinbrecher Ricarda Genetic Engineering in plants and the ldquoNew Breeding Techniques (NBTs)rdquo December 2015

httpwwweconexusinfopublicationgenetic-engineering-plants-and-new-

Corporate Europe Observatory and Inf OGM TTIP released emails show biotech seeds on the trade talks table 2 July 2015

httpcorporateeuropeorgfood-and-agriculture201507ttip-released-em

The Working Group was made up of two experts nominated from each member state Its final report was completed in 2012 but was never officially

published

See for a description of the techniques and reasons why they should be regulated Steinbrecher Ricarda Genetic Engineering in plants and the ldquoNew

Breeding Techniques (NBTs)rdquo December 2015 httpwwweconexusinfopublicationgenetic-engineering-plants-and-new-

Testbiotech Gene-editing and plants amp animals used in food production some technical socio-economic and legal aspects Backgrounder for Hearing on

ldquoNew Techniques for Plant Breedingrdquo in the EP Agriculture Committee 1 December 2015

httpwwwtestbiotechorgsitesdefaultfilesLegal20and20technical2

Waltz Emily Tiptoeing around Transgenics In Nature Biotechnology volume 30 number 3 March 2012

NBT Platform Fact sheet New Breeding Techniques Seizing the opportunity Version 2013

The Commission prioritised these techniques specifically since they entail ldquothe introduction of exogenous [that is lsquoforeignrsquo] genetic material into the

host which is the case for these techniques as it is for transgenesisrdquo

DG SANCO Steering note for NBT Platform meeting ldquoThe future of plant breeding techniques in the European Union 25 June 2014 Obtained through

Freedom of Information request by CEO

Several additional pieces of analysis were allocated to the Commissions Joint Research Centre (JRC)

EFSA Scientific opinion addressing the safety assessment of plants developed using cisgenesis and intragenesis 2012

httpwwwefsaeuropaeufrefsajournalpub2561

DG SANCO Background brief at the occasion of visit Mr Ladislav Miko to Keygene 26 January 2012 Obtained through Freedom of Information request

by CEO

DG SANCO Presentation on New Breeding Techniques at European Seed Association Annual Meeting 15 October 2012 Obtained through Freedom of

Information request by CEO

DG SANTE Email to NBT Platform 02 July 2015 Obtained through Freedom of Information request by CEO

European Parliament Follow up to the European Parliament resolution on ldquoPlant breeding what options to increase quality and yieldsrdquo (EP reference

number A7-00442014 P7_TA-PROV(2014)0131) 28 May 2014

BASF Letter to DEFRA 29 April 2013 Obtained through Freedom of Information request by GeneWatch

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

Finnish Board of Gene Technology Letter to Paolo Testori Coggi Director-General of DG SANCO 17 February 2014 Obtained through Freedom of

Information request by CEO

DG SANCO Letter to Finnish Board for Gene Technology 25 April 2014 Obtained through Freedom of Information request by CEO

NBT Platform two-pager April 2015 httpwwwnbtplatformorgbackground-documentsfactsheets2-pager-nbt-p

Bussink Michiel De strategie in Nederland Geen slapende honden wakker maken In Milieudefensie Magazine 1999-3

RTRS website Accessed 10 December 2015 httpwwwresponsiblesoyorgabout-rtrsgovernancetask-forcestask-for

Corporate Europe Observatory Roundtable on Responsible Soya - The certifying smokescreen 22 May 2012

httpcorporateeuropeorgsitesdefaultfilespublicationsrtrs_briefin

DG Trade Report from meeting with NBT Platform 07 June 2012 Obtained by Freedom of Information request by CEO

European Seed Association Position paper New Breeding Techniques ndash ensuring Progress and Diversity in Plant Breeding July 2012

httpswwweuroseedseusystemfilespublicationsfilesesa_1204462pdf

NBT Platform Fact sheet New Breeding Techniques Seizing the opportunity Version 2013

Cnudde F Dow Agrosciences Presentation Use of Zinc Finger Nucleases for plant breeding purposes May 2012 Obtained through Freedom of

Information request by CEO

Steinbrecher Ricarda Genetic Engineering in plants and the ldquoNew Breeding Techniques (NBTs)rdquo December 2015

httpwwweconexusinfopublicationgenetic-engineering-plants-and-new-

- httpswwwgrainorgesarticleentries588-gm-soybean-latin-america-s-

- httpslasojamatanetfilesparaguay-humanrights-reportpdf

Testbiotech Gene-editing and plants amp animals used in food production some technical socio-economic and legal aspects Backgrounder for Hearing on

ldquoNew Techniques for Plant Breedingrdquo in the EP Agriculture Committee 1 December 2015

httpwwwtestbiotechorgsitesdefaultfilesLegal20and20technical2

Fagan J Antoniou M Robinson C Earth Open Source GMO Myths and Truths 2014 httpgmomythsandtruthsearthopensourceorg

Greenpeace Twenty years of failure Why GM crops have failed to deliver on their promises November 2015

httpwwwgreenpeaceorginternationalGlobalinternationalpublication

NBT Platform two-pager April 2015 httpwwwnbtplatformorgbackground-documentsfactsheets2-pager-nbt-p

NBT Platform Email to DG Trade 18 May 2015 Obtained through Freedom of Information request by CEO Doc 2 A2D Trade

NBT Platform two-pager April 2015 httpwwwnbtplatformorgbackground-documentsfactsheets2-pager-nbt-p

EU Transparency Register Accessed 11 January 2016 httpeceuropaeutransparencyregisterpublicconsultationdisplaylobb

The lobbying activities covered by the register include all those that are ldquocarried out with the objective of directly or indirectly influencing the

formulation or implementation of policy and the decision-making processes of the EU institutions irrespective of where they are undertaken and of the

channel or medium of communication used for example via outsourcing media contracts with professional intermediaries think tanks platforms

forums campaigns and grassroots initiativesrdquo Article 7 httpeur-lexeuropaeulegal-contentENTXTHTMLuri=CELEX32014Q0919

Website NBT Platform Accessed 8 November 2015 Compared to a list provided in 2014 two members dropped off Cellectis Plant Sciences and Centre

RampD Nestleacute Tours httpwwwnbtplatformorg

DG SANCO Steering note for Mr Ladislav Miko at the occasion of a visit by Mr Hugo von Meijenfeldt Acting DG Environment Environment Ministry

Netherlands 15 November 2012

DG Trade Report from meeting with NBT Platform 07 June 2012 Obtained by Freedom of Information request by CEO

Inova Fruit is owned by five shareholders all large fruit auction companies 49 of shares are owned for instance by the Greenery that has over 1400

employees

For example Rothamsted Research website As accessed 11 January 2016 httpwwwrothamstedacuknewsnew-collaborative-research-project-gets

VIB website As accessed 21 December 2015 httpwwwvibbenlover-viborganisatiePaginasAlgemene-vergaderingaspx

ENERGYPOPLAR website As accessed 21 December 2015 httpwwwenergypoplareuinstitutionsphpid=40

NBT Platform two-pager April 2015 httpwwwnbtplatformorgbackground-documentsfactsheets2-pager-nbt-p

DG SANCO Notes of meeting with NBT Platform of 31 May 2012 06 June 2012 Obtained through Freedom of Information request by CEO

NBT Platform Proposed agenda for meeting on 22 June 2012 Obtained through Freedom of Information request by CEO

Schouten Henk Wageningen University and Research Center and Inova Fruit Presentation to European Commission Legal arguments to keep plants

from novel breeding techniques such as cisgenesis outside the GMO regulation 22 June 2012 Obtained through Freedom of Information request by CEO

Kempen F C Jung Genetic Modification of Plants Agriculture Horticulture and Forestry 2010 In Biotechnology in Agriculture and Forestry Springer

httpelibrarycomngUploadFilesfile0_10097pdf

Schuttelaar amp Partners was also hired for this project to draw up a communication plan ldquofor the acceptance and marketingrdquo of the cisgenic apple

National Academic Research and Collaborations Information System website As accessed 12 January 2016

httpwwwnarcisnlresearchRecordIDOND1310571

NBT Platform Email to DG SANCO 10 July 2012 Obtained through Freedom of Information request by CEO

17

18

19

20

21

22

23

24

25

26

27

28

29

30

31

32

33

34

35

36

37

38

39

40

41

42

43

44

45

46

47

48

49

DG Trade Report from meeting with NBT Platform 07 June 2012 Obtained through Freedom of Information request by CEO

DG Trade Report from meeting with Schuttelaar amp Partners on new breeding techniques 15 March 2012 Obtained through Freedom of Information

request by CEO

European Seed Association (ESA) Position paper Promoting and Enabling Innovation in Plant Breeding February 2014 Obtained through Freedom of

Information request by CEO

NBT Platform Legal Briefing Paper The regulatory status of plants resulting from New Breeding Technologies Version of 28 May 2013 Obtained

through Freedom of Information request by CEO

NBT Platform Summary of Legal Briefing Paper ldquoThe regulatory status of plants resulting fromNew Breeding Technologiesrdquo Obtained through Freedom

of Information request by CEO 22 May 2013 doc 512

The Directive 200118 (Annex 1B) lists two techniques ndash cell fusion and mutagenesis ndash for which an exemption has been granted and that are therefore

excluded from its scope As these two techniques predated the Directive by many years EU authorities assumed there was a lsquohistory of safe usersquo

The following documents exemplify the pro-deregulation arguments Each uses one or more of the points listed in the table

- European Technology Platform Plants for the Future Position paper New Breeding Techniques - Ensuring an Innovative and Diversified European

Agriculture September 2012 httpwwwepsoweborgfile1096

- European Seed Association Regulatory approaches to modern plant breeding - the case of mutagenesis and new gene editing technologies 20 July 2015

httpswwweuroseedseusystemfilespublicationsfilesesa_150543_0pdf

- CropLife International Position Paper Regulatory oversight of products developed through new breeding techniques 2014 httpscroplifeorgwp-

contentuploadspdf_filesRegulatory-Oversight-o

- NBT Platform Factsheet Oligonucleotide-Directed Mutagenesis accelerating innovation 2013 httpwwwnbtplatformorgbackground-

documentsfactsheetsfactsheet-oli

- NBT Platform Legal Briefing Paper The regulatory status of plants resulting from New Breeding Technologies Version of 28 May 2013

- Kraumlmer L Legal questions concerning new methods for changing the genetic conditions in plants Legal analysis commissioned by Arbeitsgemeinschaft

baumluerliche Landwirtschaft (AbL) Bund fuumlr Umwelt und Naturschutz (BUND) etc September 2015

httpwwwtestbiotechorgsitesdefaultfilesKraemer_Legal20questions

- Spranger TM Legal Analysis of the applicability of Directive 200118EC on genome editing technologies Commissioned by the German Federal Agency

for Nature Conservation October 2015 httpbfndefileadminBfNagrogentechnikDokumenteLegal_analysis_of_g

- Cotter J Zimmermann D Van Bekkem H Greenpeace Applications of the EU and Cartagena definitions of a GMO to the classification of plants

developed by cisgenesis and gene-editing techniques 2015 httpwwwgreenpeacetogreenpeacewp-contentuploads201511Applicati

- Reseau Semences Paysannes Confederation Paysanne et al Statut juridique des produits issus des nouvelles techniques de modification geacuteneacutetique des

plantes

DG SANCO Notes from meeting with NBT Platform 21 March 2014 Obtained through Freedom of Information request by CEO

NBT Platform and ETP Plants for the Future Meeting report Multilateral meeting lsquothe future of plant breeding techniques in the European Unionrsquo

Obtained through Freedom of Information request by CEO 25 June 2014

Ibid

Dow Agrosciences and DG SANCOJRC Emails April 2012 and July 2013 Obtained through Freedom of Information request by CEO

DG SANCO Internal email 8 July 2013 Obtained through Freedom of Information request by CEO

Corporate Europe Observatory and Inf OGM TTIP released emails show biotech seeds on the trade talks table 2 July 2015

httpcorporateeuropeorgfood-and-agriculture201507ttip-released-em

European Commission Letter to Competent Authorities 5 June 2015 Obtained through Freedom of Information request by CEO

Cibus Europe Letter to DG SANCO January 2015 Obtained through Freedom of Information request by CEO

Schuttelaar amp Partners Letter to Commissioner Vytenis Andriukaitis 1 December 2014 Obtained through Freedom of Information request by CEO

NBT Platform Email to Mr Ladislav Miko (DG SANTE) 26 February 2015 Obtained through Freedom of Information request by CEO

NBT Platform Email to DG Trade 18 May 2015 Obtained through Freedom of Information request by CEO

According to Agrafacts the non-paper was authored by German UK Irish and Spanish authorities

Non-paper on the regulatory status of plants generated by oligonucleotide-directed mutagenesis (ODM) 21 May 2015 Obtained through Freedom of

Information request by CEO

BVL Legal interpretation to DG SANTE 28 September 2015 Obtained through Freedom of Information request by CEO

DG SANTE Reply to Vlaams Instituut voor Biotechnologie (VIB) 9 July 2015 Obtained through Freedom of Information request by CEO (doc 24 a2d3)

Vlaams Instituut voor Biotechnologie (VIB) Letter to Mr Ladislav Miko (DG SANTE) 10 June 2015 Obtained through Freedom of Information request by

CEO

DG SANTE Reply to Vlaams Instituut voor Biotechnologie (VIB) 9 July 2015 Obtained through Freedom of Information request by CEO

Vlaams Instituut voor Biotechnologie (VIB) Email to DG SANTE 6 July 2015 Obtained through Freedom of Information request by CEO

VIB Fact series Een schimmelresistente aardappel voor Belgieuml December 2014

50

51

52

53

54

55

56

57

58

59

60

61

62

63

64

65

66

67

68

69

70

71

72

73

74

Food and agriculture

Attached files Attached files

1_briefing_visit_keygenepdf

6pdf

13_presentation_at_esa_-_15-10-2012pdf

14_briefing_visit_nl_dg_2pdf

26_letter_from_fi_registered_versionpdf

30_bto_meeting_with_nbpt-2_registered_versionpdf

34_reply_to_finland_25-4-2014_registered_versionpdf

36_nbt_platform_multilateral_meeting_25_06_2014_steering_note_registered_versionpdf

42_e-mail_dow_agro_to_jrc_-_10-4-2012pdf

431_presentation_cnudde_31-5-2012pdf

44_bto_meeting_31-5-2012pdf

45_proposed_agenda_meeting_22-6-2012pdf

462_ppt_schouten_22-6-2012pdf

51_e-mail_nbt_platform_31-5-2013pdf

511_legal_briefing_paper_-_28-5-2013pdf

512_summary_legal_paper_22-5-2013pdf

513_nbt_factsheetspdf

53_e-mail_from_dow_agro_to_sanco_2-7-2013pdf

54_internal_e-mail_dg_sanco_8-7-2013pdf

561_esa_position_paper_-_fev_2014pdf

57_invitation_to_the_meeting_on_the_future_of_plant_nbts_in_the_eu_25_06_2014pdf

nbt_platform_multilateral_meeting_ares20144089348_-_signed_version_-_third_batchpdf

9pdf

6pdf

12pdf

18pdf

17_20150610_vib_letter_redactedpdf

18_20150615_lettre_autorites_competentes_redactedpdf

21_20150702_reply_to_nbtp-redactedpdf

24_20150709_reply_to_vib_redactedpdf

27_20150722_vib_redactedpdf

28_bto_-_meeting_l_miko_with_new_breeding_technique_platform_-_27_april_2015_redactedpdf

atd_2015-5344_-_doct_2pdf

atd_2015-5344_-_doct_7pdf

atd_2015-5344_-_doct_8pdf

ares20155217184annex-ms_non_paperpdf

httpwwwvibbenleducatieDocumentsVIB_dossier_20schimmelresistent

EASAC Statement on New Breeding Techniques July 2015 httpwwweasaceufileadminPDF_sreports_statementsEasac_14_NBTpdf

EASAC Planting the Future - opportunities and challenges for using crop genetic improvement technologies for sustainable agriculture June 2013

httpwwweasaceufileadminReportsPlanting_the_FutureEASAC_Planting

However one third of the working group are also member of PRRI an industry-minded lobby group of public scientists

Corporate Europe Observatory PRRI - Are these public researchers 2008 httpcorporateeuropeorgfood-and-agriculture200806prri-are-these-p

European Parliament Committee on Agriculture Hearing on ldquoNew Techniques for Plant Breedingrdquo 1 December 2015

httpspolcmssecureeuroparleuropaeucmsdatauploadd35d2641-ab77-49

Furthermore Schuttelaar amp Partners now lists only one client (Grodan a supplier to the horticulture sector) This is in sharp contrast to the lobby firmrsquos

own website where 11 clients from the food and biotech sectors are listed as examples of ldquocurrent and recent clientsrdquo

Schuttelaar amp Partners website As accessed 13 December 2015 httpwwwschuttelaar-partnerscomclients

EU Transparency Register website As accessed 15 November 2015 (No longer in public domain available from CEO)

EU Transparency Register Accessed 16 January 2016

Dorotheacutee Andreacutee DG SANTE Comment at EP Agriculture Committee hearing 1 December 2015

75

76

77

78

79

80

81

0

14_09-28_letter_de_redactedpdf

Tag Tag

genetically modified crops

GMOs

Belgian showfield of DutchGM DuRPhpotatoes

Related Latest

REPORT

Of apples and potatoesthe Dutch lobby for thederegulation ofcisgenesisFEBRUARY 2ND 2016 THE POWER OF

LOBBIES FOOD AND AGRICULTURE

The voice of the Dutch Government has been

loud and clear in Brussels on the issue of

cisgenic plants The Dutch have waged a

sustained campaign to have new GM

techniques ndash and in particular cisgenesis ndash

excluded from EU GMO regulations Several

Dutch ministries the Dutch Parliament the

Dutch Permanent Representation in Brussels

and Dutch MEPs have energetically pursued

this goal

STORY

Canadian company railroads EUdecision-making on new GM

FEBRUARY 2ND 2016 THE POWER OF LOBBIES FOOD AND

AGRICULTURE

At least one developer of new GM crops ndash

Canadian-based Cibus ndash has attempted to

bypass the European policy process by

presenting policy makers with a fait accompli

decisions by individual Member States on the

regulatory status of new techniques as well as

prematurely-launched trials of new GM crops

STORY

EU review of weedkillerglyphosate adds secrecyto controversy

JANUARY 14TH 2016 EFSA FOOD AND AGRICULTURE

More than 80 per cent of the national experts

involved in the EUs official assessment of

glyphosate refused to have their names

disclosed to the public

STORY

Solutions COP21Climate SmartAgriculture boostingthe technofix

DECEMBER 10TH 2015 CLIMATE AND ENERGY FOOD AND

AGRICULTURE

ldquoIf you like greenwashing clap your handsrdquo

1 of 321 of 32 next rsaquo

Corporate Europe Observatory

(CEO) is a research and campaign

group working to expose and

challenge the privileged access

and influence enjoyed by

corporations and their lobby

groups in EU policy making

Read more

CEO relies on grants and

donations to carry out our

research and campaign work By

making a donation or becoming a

friend of CEO you help to

support our efforts to expose

corporate lobbying increase

transparency and urge greater

democratic accountabililty in the

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Or

All written content on this

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Creative Commons Attribution-

NonCommercial-ShareAlike 30

Unported License

Page 5: FOROEUROPA - Biotech lobby’s push for new GMOs to escape … · 2016-02-04 · With respect to cisgenesis and intragenesis, EFSA concluded that while intragenic plants would generate

also at some point members of the Platform and in any case attended NBT meetings

The NBT Platform does not let an opportunity pass to stress the interests of SMEs and research institutes in its lobby to get new

GM deregulated However taking the EU definition of a SME as a company with fewer than 250 employees only three Platform

members qualify KeyGene Meiogenix and SweTree Technologies Furthermore some of the lsquopublicrsquo research institutes that the

NBT Platform represents have strong financial ties with industry For instance Rothamsted Research (UK) has many joint projects

with agribusiness corporations And no less than one third of the general council membership of the Flemish Biotechnology

Institute (VIB) is made up of industry representatives including Syngenta and Bayer

Indeed it is important to note that both biotech SMEs and (semi-) public research institutes often play the role of technology

suppliers for big multinationals SweTree Technologies for example is engaged in the development of GM trees and claims to have

applied for 75 patents in that field Some of these products have already been licensed to BASF and SweTree Technologies claims to

collaborate with the corporation in several areas

4 Multi-phased lobby campaign against EU GMO regulation

The NBT Platformrsquos website clearly delineates the four phases of its campaign to give the death blow to GMO regulation for new

GM products

Source NBT Platform website

Following the creation of the NBT Platform in the first phase the second phase in the industryrsquos lobby campaign to the European

Commission was characterised by repeated efforts to showcase the new techniques and their claimed benefits as well as the

provision of technical and legal arguments for why they should go unregulated

In the spring of 2012 for example Schuttelaar amp Partners teamed up to chair two meetings presenting new GM techniques to staff

from DG SANCO DG Trade and DG Research and Innovation Dow presented Zinc Finger Nuclease (ZFN) technology Rijk

Zwaan introduced agroinfiltration and reverse breeding BayerNunhems explained cisgenics KeyGene made a pitch for ODM and

VIB put forward grafting on GM root stock Syngenta and Inova Fruit were also present at the meetings

In addition a legal argumentation as to why the EU should not regulate ODM and cisgenics techniques in particular was presented

by Wageningen University plant researcher Henk Schouten who was also wearing his hat as lobbyist for Inova Fruit Inova Fruit

owned by large Dutch and Flemish fruit traders contracted the private arm of Wageningen University to develop cisgenic apple

varieties Both Wageningen University and Inova Fruit clearly have commercial interests in getting cisgenesis deregulated This

shows the involvement of Wageningen University in private interest lobbying despite its public denial of this kind of activity (See

case study Of apples and potatoes the Dutch lobby for the deregulation of cisgenesis)

In May 2013 the NBT Platform presented the Commission with

37 38

39

40

41

42

43

44 45

46

47 48

Trade concerns (1) avoiding disruptions at all costs

In lobbying the Commission DG Trade was not left out In a first

meeting in March 2012 Schuttelaar amp Partners raised their clientsrsquo

concerns about ldquothe legislative uncertaintyrdquo for new GM

techniques and added that in this field ldquothe EU occupies the

second place in the world for patent applications with the UK and

the Netherlands contributing most significantlyrdquo In late May

2012 Schuttelaar amp Partners staged a second larger meeting

attended by DG SANCO DG Trade and ldquoNBT Platform membersrdquo

Dow Agrosciences VIB KeyGene Syngenta Bayer CropScience

Rothamsted Research Rijk Zwaan and Wageningen University

Their message did not fall upon deaf ears After the first meeting a

DG Trade official concluded that his DG would ldquohave to ensure

that any measuresolution proposed will not result in trade

disruptionsrdquo And furthermore he reported ldquoI was reassured by my

SANCO counterparts that the trade angle will be taken into

account when deciding on the Commissionrsquos line to takerdquo

The European Seed Association announced to DG SANCO that it

wanted new GM techniques deregulated and specifically attacked

the EU traceability and labelling requirements for their ldquopotential

to hamper free traderdquo

its piegravece de reacutesistance the industryrsquos own lsquolegal interpretationrsquo of

the regulatory status of new GM techniques This was based on

a sort of questionnaire consisting of seven main questions (and

many subquestions) that it is explained must all be answered in

the affirmative in order for a product to be regulated as a GMO

This methodology was carefully designed to ensure the desired

outcome that all of the new GM techniques in question should

be unregulated and by extension untested and unlabelled

Source NBT Platform website

Question 3 and 4 aim to twist the definition of a GMO in EU Directive 200118 which is ldquoan organism with the exception of

human beings in which the genetic material has been altered in a way that does not occur naturally by mating andor natural

recombinationrdquo Using industrys methodology most of the new techniques would escape regulation as they can provide a negative

answer to one of these two questions The Platform analysis also argues that some of the new GM techniques are simply a

variation of mutagenesis (a technique that had long been in use when Directive 200118 was developed and that was explicitly

excluded from its scope) Furthermore the industry approach aims to undermine the process-based nature of the Directive as

described earlier

The arguments put forward by the NBT Platform are at the core of industrys rationale for the deregulation of new GM These

points or variations on them can also be found in lobby documents produced by the European Seed Association (ESA) the

European Plant Science Organisation (EPSO) the pesticide lobby group Croplife International and the Flemish biotech research

institute VIB

The pro-deregulation interpretation of the scope of Europersquos GM laws has been met with wide-ranging criticism Counter-

arguments have been provided by German federal agencies (for example the opinion by Professor Tade Matthias Spranger for BfN

the German Federal Agency of Nature Conservation) a legal analysis by Professor Ludwig Kraumlmer as commissioned by German civil

society and assessments by Greenpeace farming and other environmental groups Similarly industryrsquos attempt to have new GM

49

50

51

52

53

54

55

declared safe by design and therefore exempt from regulatory risk assessment has been countered by the Austrian Environmental

Agency and various non-governmental organisations

The legal case that new GM techniques should be covered by the current regulations is in fact crystal clear

The central purpose of Directive 200118 on the deliberate release of GMOs is to protect human health and the environment from

the release of genetically modified organisms The Directive clearly provides for the advent of new GM techniques which rely upon

in vitro methods to directly modify genomes These are the very type of techniques that EU law covers with its process-based

approach (where the technique used decides if the regulations apply) That process-based regulation and the precautionary

approach that lies at the heart of the directive are justified because of the unintended and unexpected effects of both GM 10 and

GM 20 techniques Techniques that have been developed since 2001 (or that didnt have any commercial application prior to 2001)

cannot be regarded as industry argues the same as traditional mutagenesis techniques that were exempted on the grounds of a

claimed history of safe use when the EU regulations were introduced

The key arguments from industry and counter-arguments are summarised in the following table

Table Key industry arguments for the deregulation of new GM techniques

Industry argument Response

1 ldquoNew GM is just l ike traditional plant1 ldquoNew GM is just l ike traditional plant

breedingrdquobreedingrdquo

Products from new GM are just like traditionally bred

plants since ldquono foreign DNA is usedrdquo Industry seeks to

reframe the legal interpretation of a GMO in this way

because many of the new techniques do not necessarily

use DNA from another species or use genetic material

other than DNA

In EU law a GMO does not need to contain foreign DNA to qualifyIn EU law a GMO does not need to contain foreign DNA to qualify

as a GMOas a GMO

The Directive refers to ldquoan organism hellipin which genetic material has been

altered in a way that does not occur naturally by mating andor natural

recombinationrdquo The new techniques directly modify an organismrsquos genetic

material without involving mating and are therefore genetic engineering In

addition the Directive also qualifies the introduction of other types of genetic

material than DNA as GM

2 ldquoJust because a GM technique is used does2 ldquoJust because a GM technique is used does

not mean that the product is legally a GMOrdquonot mean that the product is legally a GMOrdquo

If there is no GM material present in the final product

it should not be treated as a GMO This is an attack on

the process-based (technique-based) nature of the

Directive and would mean that products of several

methods that do involve GM would be exempt

The EU has The EU has recognisedrecognised that the GM that the GM technique usedtechnique used to to changechange an an

organisms organisms does does mattermatter

Itrsquos the genetic engineering process that can lead to unintentional alterations

of the genetic material giving rise to concerns regarding food and

environmental safety These concerns remain even if the genetic engineering

agent is subsequently removed

3 ldquoGene editing techniques are a form of3 ldquoGene editing techniques are a form of

mutagenesis rdquomutagenesis rdquo

Mutagenesis is excluded from the scope of the

Directive as it was assumed to have a history of safe

use

New gene editing techniques are different and have no histor y ofNew gene editing techniques are different and have no histor y of

safe usesafe use

They are different from the mutagenesis techniques (chemical and radiation)

referred to in the Directive

4 ldquoNew GM is safe by designrdquo4 ldquoNew GM is safe by designrdquo

The claim is that the genetic interventions are precise

and targeted and therefore safe This is reflected by the

terms used gene or genome editing

New GM techniques can have multiple unintended and unexpectedNew GM techniques can have multiple unintended and unexpected

results results

New GM methods pose very similar types of risks as GM 10 and should be

regulated at minimum in the same way as existing GMOs in order to protect

the environment and public health Precision in changing the genetic makeup

of an organism does not equate safety if you do not fully understand the

impacts

5 ldquoDetection is impossiblerdquo5 ldquoDetection is impossiblerdquo

Industry claims that detection methods will not be able

Detection methods are evolving as are genetic engineeringDetection methods are evolving as are genetic engineering

techniques techniques

56 57

Trade concerns (2) TTIP kicks in

Another line of argument pursued by the NBT Platform is the

comparison of how new GM techniques are regulated ndash or not ndash in

other parts of the world cumulating in the suggestion that a

stronger level of regulation in the EU will create trade barriers

In the context of TTIP the way the US deals with the new

techniques is of particular interest For example US-based

multinational Dow informed DG SANCO in 2013 of the decision by

the US Department of Agriculture (USDA) to not regulate Dows

ZFN-1 maize The Commission later reflected however that the

US Food and Drug Administration (FDA) ldquoremains rather vaguerdquo on

the issue It should be noted that the US hardly regulates GMOs

as such There are no formal data requirements when it comes to

safety testing and biotech companies voluntarily provide whatever

information they please

Emails released by the Commission provide evidence that the (de-

)regulation of new GM techniques was indeed discussed in a March

2014 TTIP-related meeting in Washington Despite repeated claims

at the time by the Commission that ldquoGM is not on the tablerdquo US

and EU authorities sat together with seed industry lobby groups

from both sides of the Atlantic (including the European Seed

Association)

to tell the difference between a new GM and a

traditionally-bred product

While distinguishing some new GM products from non-GM products may

currently be difficult this is very likely to change in the future

6 ldquoApplication of the precautionar y principle6 ldquoApplication of the precautionar y principle

should be reconsideredrdquoshould be reconsideredrdquo

Industry claims that since there is less uncertainty

related to new gene editing techniques than with

mutagenesis using radiation or chemical mutagens and

since the precautionary principle is about uncertainty it

should not be applied to new GM techniques

Precautionar y principle should be respectedPrecautionar y principle should be respected

The precautionary principle and the process-orientated approach to risk

assessment as established under EU law can only be implemented if the new

methods are covered by the Directive

5 Last phase lobbying

The third phase of the industry campaign indicated in the graph by lsquoPoliticsPublic Affairsrsquo (read Lobby) kicked in with a so-

called multi-stakeholder meeting held on 25 June 2014 lsquoThe future of plant breeding techniques in the European Unionrsquo was a

co-production of the NBT Platform and the industry-driven European Technology Platform Plants for the Future However the

NBT Platform cast a narrow net when inviting lsquostakeholdersrsquo on its list were the Member States Competent Authorities the

Commission and companies and their lobby associations (eg the European Seed Association farming lobby Copa-Cogeca and so

forth) Absent were environmental and consumer NGOs sustainable farming organisations and the like

The industry campaign escalated during this phase with dire predictions of economic collapse and job losses following the

eventual regulation of new GM According to the NBT Platform multi-stakeholder meeting report for example industrial farming

group Copa-Cogeca said that ldquooverly strictrdquo regulation would ldquoincrease unfair competitionrdquo for farmers In turn the European Plant

Science Organisation (EPSO) insisted that the current legal uncertainty was causing ldquointelligence leakagerdquo and destroying jobs

while another participant went as far as to warn that this ambiguity would lead to the ldquocomplete extinctionrdquo of a large part of the

plant breeding sector in Europe

By the start of 2015 the Commission appeared close to reaching

a decision on new GM techniques and things were starting to

heat up

In the spring the German Government decided to take matters

into its own hands It determined that Cibus ODM oilseed rape

did not qualify as a GMO so that field trialling could proceed

with no regulation or monitoring In response the Commission

quickly sent letters to Germany and all EU member states asking

them to ldquoawait as much as possible the outcome of the

Commission legal interpretation before authorising a deliberate

release of organisms obtained with new plant breeding

techniquesrdquo since ldquothe deliberate release of products which are

subject to the rules of the EU GMO legislation without

appropriate prior authorisation is illegalrdquo (See case study

Canadian company railroads EU decision making on new GM)

But Cibus also informed the Commission that as its product was

already being grown in the US ldquothe harvested material is used

like any other crop and likely entering the international

commodity chainrdquo According to the company the possibility of

this unauthorised GM oilseed rape being imported into the EU

could therefore not be excluded

Following the May 2014 elections a new Commissioner in charge

of DG SANTE (previously called SANCO) was installed the

Lithuanian Vytenis Andriukaitis The NBT Platform set the

58

59

60

61

62

63

64

65

66

necessary liaison efforts into motion and set up a meeting that took place in July 2015 The Platform also shifted focus to liaise

and gather information from EU member states and sought a meeting with the Commission (DGs SANTE AGRI and Trade) to

report back on these contacts

Furthermore at two occasions in 2015 GM developers got assistance from certain member states that have also been peddling a

pro-deregulation agenda with Brussels In May 2015 a lsquonon-paperrsquo authored by Germany the UK Ireland and Spain argued for the

deregulation of the ODM technique in particular using the same arguments as put forth by industry to argue that ldquoODM is a

variation of mutagenesisrdquo

In September the German food safety agency BVL in a joint exercise with its UK and Irish colleagues sent an interpretation of the

definition of a GMO in Directive 200118 to the Commission This document precisely echoes the industry discourse that a

product should only be regulated under EU GMO laws if it is produced by a GM process and if the result is a product that could

not have been achieved in a lsquonaturalrsquo way

Flemish biotechnology institute (VIB) and EASAC join the chorus

In this last phase corporate-backed research institutes like the Flemish VIB also stepped up their efforts in order to defend their

commercial interests On 5 June 2015 the VIB met with the Commission to discuss a number of new techniques Although the list

has not been disclosed following freedom of information requests according to the VIB ldquo the examples given represent concrete

business opportunities and vulnerable information from the viewpoint of competitionrdquo It appears likely from the Commission response

and a related email exchange on the topic that the VIB is eyeing cisgenesis and certain gene editing techniques VIB has an obvious

commercial interest in the deregulation of cisgenesis after having put its money on turning the failed Dutch cisgenic potato into a

Belgian specialty a blight-resistant Bintje a well known potato variety widely used for the countrys famous fries

Moreover in a remarkable statement addressed to the Commission in July 2015 the European Academies Science Advisory Council

(EASAC) also backed industrys views Their political demands dovetail with those of industry GMOs should be allowed to escape

regulation ldquowhen they do not contain foreign DNArdquo that GM products should be regulated only by trait and not technique and that the

use of the precautionary principle in GM regulation should be reconsidered The statement is based on the conclusions of an earlier

EASAC report Planting the Future This report was composed by a working group of experts acting in individual capacity nominated

by member academies of EASAC

Meanwhile in the European Parliament some MEPs unsuccessfully demanded a formal say in the process Others including Jan

Huitema (Liberals) and Anthea McIntyre (Conservatives) authored resolutions that included calls for the deregulation of new GM

techniques On 1 December 2015 a hearing took place in the European Parliament Agriculture Committee Edwin Hecker a NBT

Platform lobbyist and an employee of Schuttelaar amp Partners (although the latter was not disclosed) presented industrys views

again overstating the role of SMEs

Surprisingly only one week later the NBT Platform was deleted from Schuttelaar amp Partners list of clients in the register However

the information in the NBT Platforms entry and on its website remains unchanged (See box Does the NBT Platform still exist)

Does the NBT Platform still exist

Schuttelaar amp Partners made some remarkable changes to their registry entry on 7 December 2015 The NBT Platform has been deleted

as a client from the lobby groups entry This is contradictory as the NBT Platformrsquos entry is unchanged and still lists Mr Hecker as its

chair In line with this change the Commissions legal interpretation of Directive 200118 for the new GM techniques has been deleted

from the list of EU initiatives followed by the company

In addition the companys overall lobby-related expenses have been reduced tenfold from euro100000-500000 down to euro50000-99000

The consultancy now declares just a 08 FTE workload for lobbying activities This is at odds for instance with the fact that ten

employees currently hold lobby passes for the European Parliament

6 The Commissions interpretation Whose interests will prevail

All invested parties are now awaiting the Commissions decision to be presented in March 2016 Will the NBT Platform be

celebrating victory after achieving its Phase 4 Agreement goal Or will concerned governments NGOs and sustainable farming

67

68

69

70 71

72 73

74

75

76

77

78

79

80

organisations be relieved that the new GM technologies will be subject to the existing hard-won regulation

Maybe neither DG SANTE has already publicly stated that ldquosome will be pleased others disappointedrdquo indicating that at least

one perhaps more but not all of the new techniques will escape regulation as a result of the Commission decision If true this

would ndash no matter how many techniques are concerned ndash be a serious attack on food and environmental safety consumer choice

and transparency in the food chain as well as enhancing corporate concentration in the seed sector through patents

As Brussels itself realises the Commission release is probably just the beginning ndash and not the resolution ndash of this contentious

issue In all likelihood it will be the European Court of Justice that ultimately determines the regulatory fate of new GM

techniques The court case brought by environmental and farming organisations against Cibus ODM oilseed rape will therefore be

of great importance

In the meantime neither the biotech industry nor its financiers are likely to have the certainty they have been striving for

Furthermore other actors may still come into play Food distributors may demand direct liability for new GM products to those

who put them on the market And parliaments may insist on the labelling of new GM products like has happened in the

Netherlands The TTIP negotiations on the other hand may become a force against a proper regulation of GM 20 Environmental

and sustainable farming groups will have to remain on high alert

81

- Eckerstorfer M et al Environmental Agency Austria Technical report New plant breeding techniques and risks associated with their application 2014

httpwwwumweltbundesamtatfileadminsitepublikationenREP0477pd

- Kraumlmer L Legal questions concerning new methods for changing the genetic conditions in plants Legal analysis commissioned by Arbeitsgemeinschaft

baumluerliche Landwirtschaft (AbL) Bund fuumlr Umwelt und Naturschutz (BUND) etc September 2015

httpwwwtestbiotechorgsitesdefaultfilesKraemer_Legal20questions

- Spranger TM Legal Analysis of the applicability of Directive 200118EC on genome editing technologies Commissioned by the German Federal Agency

for Nature Conservation October 2015 httpbfndefileadminBfNagrogentechnikDokumenteLegal_analysis_of_g

Steinbrecher Ricarda Genetic Engineering in plants and the ldquoNew Breeding Techniques (NBTs)rdquo December 2015

httpwwweconexusinfopublicationgenetic-engineering-plants-and-new-

Corporate Europe Observatory and Inf OGM TTIP released emails show biotech seeds on the trade talks table 2 July 2015

httpcorporateeuropeorgfood-and-agriculture201507ttip-released-em

The Working Group was made up of two experts nominated from each member state Its final report was completed in 2012 but was never officially

published

See for a description of the techniques and reasons why they should be regulated Steinbrecher Ricarda Genetic Engineering in plants and the ldquoNew

Breeding Techniques (NBTs)rdquo December 2015 httpwwweconexusinfopublicationgenetic-engineering-plants-and-new-

Testbiotech Gene-editing and plants amp animals used in food production some technical socio-economic and legal aspects Backgrounder for Hearing on

ldquoNew Techniques for Plant Breedingrdquo in the EP Agriculture Committee 1 December 2015

httpwwwtestbiotechorgsitesdefaultfilesLegal20and20technical2

Waltz Emily Tiptoeing around Transgenics In Nature Biotechnology volume 30 number 3 March 2012

NBT Platform Fact sheet New Breeding Techniques Seizing the opportunity Version 2013

The Commission prioritised these techniques specifically since they entail ldquothe introduction of exogenous [that is lsquoforeignrsquo] genetic material into the

host which is the case for these techniques as it is for transgenesisrdquo

DG SANCO Steering note for NBT Platform meeting ldquoThe future of plant breeding techniques in the European Union 25 June 2014 Obtained through

Freedom of Information request by CEO

Several additional pieces of analysis were allocated to the Commissions Joint Research Centre (JRC)

EFSA Scientific opinion addressing the safety assessment of plants developed using cisgenesis and intragenesis 2012

httpwwwefsaeuropaeufrefsajournalpub2561

DG SANCO Background brief at the occasion of visit Mr Ladislav Miko to Keygene 26 January 2012 Obtained through Freedom of Information request

by CEO

DG SANCO Presentation on New Breeding Techniques at European Seed Association Annual Meeting 15 October 2012 Obtained through Freedom of

Information request by CEO

DG SANTE Email to NBT Platform 02 July 2015 Obtained through Freedom of Information request by CEO

European Parliament Follow up to the European Parliament resolution on ldquoPlant breeding what options to increase quality and yieldsrdquo (EP reference

number A7-00442014 P7_TA-PROV(2014)0131) 28 May 2014

BASF Letter to DEFRA 29 April 2013 Obtained through Freedom of Information request by GeneWatch

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

Finnish Board of Gene Technology Letter to Paolo Testori Coggi Director-General of DG SANCO 17 February 2014 Obtained through Freedom of

Information request by CEO

DG SANCO Letter to Finnish Board for Gene Technology 25 April 2014 Obtained through Freedom of Information request by CEO

NBT Platform two-pager April 2015 httpwwwnbtplatformorgbackground-documentsfactsheets2-pager-nbt-p

Bussink Michiel De strategie in Nederland Geen slapende honden wakker maken In Milieudefensie Magazine 1999-3

RTRS website Accessed 10 December 2015 httpwwwresponsiblesoyorgabout-rtrsgovernancetask-forcestask-for

Corporate Europe Observatory Roundtable on Responsible Soya - The certifying smokescreen 22 May 2012

httpcorporateeuropeorgsitesdefaultfilespublicationsrtrs_briefin

DG Trade Report from meeting with NBT Platform 07 June 2012 Obtained by Freedom of Information request by CEO

European Seed Association Position paper New Breeding Techniques ndash ensuring Progress and Diversity in Plant Breeding July 2012

httpswwweuroseedseusystemfilespublicationsfilesesa_1204462pdf

NBT Platform Fact sheet New Breeding Techniques Seizing the opportunity Version 2013

Cnudde F Dow Agrosciences Presentation Use of Zinc Finger Nucleases for plant breeding purposes May 2012 Obtained through Freedom of

Information request by CEO

Steinbrecher Ricarda Genetic Engineering in plants and the ldquoNew Breeding Techniques (NBTs)rdquo December 2015

httpwwweconexusinfopublicationgenetic-engineering-plants-and-new-

- httpswwwgrainorgesarticleentries588-gm-soybean-latin-america-s-

- httpslasojamatanetfilesparaguay-humanrights-reportpdf

Testbiotech Gene-editing and plants amp animals used in food production some technical socio-economic and legal aspects Backgrounder for Hearing on

ldquoNew Techniques for Plant Breedingrdquo in the EP Agriculture Committee 1 December 2015

httpwwwtestbiotechorgsitesdefaultfilesLegal20and20technical2

Fagan J Antoniou M Robinson C Earth Open Source GMO Myths and Truths 2014 httpgmomythsandtruthsearthopensourceorg

Greenpeace Twenty years of failure Why GM crops have failed to deliver on their promises November 2015

httpwwwgreenpeaceorginternationalGlobalinternationalpublication

NBT Platform two-pager April 2015 httpwwwnbtplatformorgbackground-documentsfactsheets2-pager-nbt-p

NBT Platform Email to DG Trade 18 May 2015 Obtained through Freedom of Information request by CEO Doc 2 A2D Trade

NBT Platform two-pager April 2015 httpwwwnbtplatformorgbackground-documentsfactsheets2-pager-nbt-p

EU Transparency Register Accessed 11 January 2016 httpeceuropaeutransparencyregisterpublicconsultationdisplaylobb

The lobbying activities covered by the register include all those that are ldquocarried out with the objective of directly or indirectly influencing the

formulation or implementation of policy and the decision-making processes of the EU institutions irrespective of where they are undertaken and of the

channel or medium of communication used for example via outsourcing media contracts with professional intermediaries think tanks platforms

forums campaigns and grassroots initiativesrdquo Article 7 httpeur-lexeuropaeulegal-contentENTXTHTMLuri=CELEX32014Q0919

Website NBT Platform Accessed 8 November 2015 Compared to a list provided in 2014 two members dropped off Cellectis Plant Sciences and Centre

RampD Nestleacute Tours httpwwwnbtplatformorg

DG SANCO Steering note for Mr Ladislav Miko at the occasion of a visit by Mr Hugo von Meijenfeldt Acting DG Environment Environment Ministry

Netherlands 15 November 2012

DG Trade Report from meeting with NBT Platform 07 June 2012 Obtained by Freedom of Information request by CEO

Inova Fruit is owned by five shareholders all large fruit auction companies 49 of shares are owned for instance by the Greenery that has over 1400

employees

For example Rothamsted Research website As accessed 11 January 2016 httpwwwrothamstedacuknewsnew-collaborative-research-project-gets

VIB website As accessed 21 December 2015 httpwwwvibbenlover-viborganisatiePaginasAlgemene-vergaderingaspx

ENERGYPOPLAR website As accessed 21 December 2015 httpwwwenergypoplareuinstitutionsphpid=40

NBT Platform two-pager April 2015 httpwwwnbtplatformorgbackground-documentsfactsheets2-pager-nbt-p

DG SANCO Notes of meeting with NBT Platform of 31 May 2012 06 June 2012 Obtained through Freedom of Information request by CEO

NBT Platform Proposed agenda for meeting on 22 June 2012 Obtained through Freedom of Information request by CEO

Schouten Henk Wageningen University and Research Center and Inova Fruit Presentation to European Commission Legal arguments to keep plants

from novel breeding techniques such as cisgenesis outside the GMO regulation 22 June 2012 Obtained through Freedom of Information request by CEO

Kempen F C Jung Genetic Modification of Plants Agriculture Horticulture and Forestry 2010 In Biotechnology in Agriculture and Forestry Springer

httpelibrarycomngUploadFilesfile0_10097pdf

Schuttelaar amp Partners was also hired for this project to draw up a communication plan ldquofor the acceptance and marketingrdquo of the cisgenic apple

National Academic Research and Collaborations Information System website As accessed 12 January 2016

httpwwwnarcisnlresearchRecordIDOND1310571

NBT Platform Email to DG SANCO 10 July 2012 Obtained through Freedom of Information request by CEO

17

18

19

20

21

22

23

24

25

26

27

28

29

30

31

32

33

34

35

36

37

38

39

40

41

42

43

44

45

46

47

48

49

DG Trade Report from meeting with NBT Platform 07 June 2012 Obtained through Freedom of Information request by CEO

DG Trade Report from meeting with Schuttelaar amp Partners on new breeding techniques 15 March 2012 Obtained through Freedom of Information

request by CEO

European Seed Association (ESA) Position paper Promoting and Enabling Innovation in Plant Breeding February 2014 Obtained through Freedom of

Information request by CEO

NBT Platform Legal Briefing Paper The regulatory status of plants resulting from New Breeding Technologies Version of 28 May 2013 Obtained

through Freedom of Information request by CEO

NBT Platform Summary of Legal Briefing Paper ldquoThe regulatory status of plants resulting fromNew Breeding Technologiesrdquo Obtained through Freedom

of Information request by CEO 22 May 2013 doc 512

The Directive 200118 (Annex 1B) lists two techniques ndash cell fusion and mutagenesis ndash for which an exemption has been granted and that are therefore

excluded from its scope As these two techniques predated the Directive by many years EU authorities assumed there was a lsquohistory of safe usersquo

The following documents exemplify the pro-deregulation arguments Each uses one or more of the points listed in the table

- European Technology Platform Plants for the Future Position paper New Breeding Techniques - Ensuring an Innovative and Diversified European

Agriculture September 2012 httpwwwepsoweborgfile1096

- European Seed Association Regulatory approaches to modern plant breeding - the case of mutagenesis and new gene editing technologies 20 July 2015

httpswwweuroseedseusystemfilespublicationsfilesesa_150543_0pdf

- CropLife International Position Paper Regulatory oversight of products developed through new breeding techniques 2014 httpscroplifeorgwp-

contentuploadspdf_filesRegulatory-Oversight-o

- NBT Platform Factsheet Oligonucleotide-Directed Mutagenesis accelerating innovation 2013 httpwwwnbtplatformorgbackground-

documentsfactsheetsfactsheet-oli

- NBT Platform Legal Briefing Paper The regulatory status of plants resulting from New Breeding Technologies Version of 28 May 2013

- Kraumlmer L Legal questions concerning new methods for changing the genetic conditions in plants Legal analysis commissioned by Arbeitsgemeinschaft

baumluerliche Landwirtschaft (AbL) Bund fuumlr Umwelt und Naturschutz (BUND) etc September 2015

httpwwwtestbiotechorgsitesdefaultfilesKraemer_Legal20questions

- Spranger TM Legal Analysis of the applicability of Directive 200118EC on genome editing technologies Commissioned by the German Federal Agency

for Nature Conservation October 2015 httpbfndefileadminBfNagrogentechnikDokumenteLegal_analysis_of_g

- Cotter J Zimmermann D Van Bekkem H Greenpeace Applications of the EU and Cartagena definitions of a GMO to the classification of plants

developed by cisgenesis and gene-editing techniques 2015 httpwwwgreenpeacetogreenpeacewp-contentuploads201511Applicati

- Reseau Semences Paysannes Confederation Paysanne et al Statut juridique des produits issus des nouvelles techniques de modification geacuteneacutetique des

plantes

DG SANCO Notes from meeting with NBT Platform 21 March 2014 Obtained through Freedom of Information request by CEO

NBT Platform and ETP Plants for the Future Meeting report Multilateral meeting lsquothe future of plant breeding techniques in the European Unionrsquo

Obtained through Freedom of Information request by CEO 25 June 2014

Ibid

Dow Agrosciences and DG SANCOJRC Emails April 2012 and July 2013 Obtained through Freedom of Information request by CEO

DG SANCO Internal email 8 July 2013 Obtained through Freedom of Information request by CEO

Corporate Europe Observatory and Inf OGM TTIP released emails show biotech seeds on the trade talks table 2 July 2015

httpcorporateeuropeorgfood-and-agriculture201507ttip-released-em

European Commission Letter to Competent Authorities 5 June 2015 Obtained through Freedom of Information request by CEO

Cibus Europe Letter to DG SANCO January 2015 Obtained through Freedom of Information request by CEO

Schuttelaar amp Partners Letter to Commissioner Vytenis Andriukaitis 1 December 2014 Obtained through Freedom of Information request by CEO

NBT Platform Email to Mr Ladislav Miko (DG SANTE) 26 February 2015 Obtained through Freedom of Information request by CEO

NBT Platform Email to DG Trade 18 May 2015 Obtained through Freedom of Information request by CEO

According to Agrafacts the non-paper was authored by German UK Irish and Spanish authorities

Non-paper on the regulatory status of plants generated by oligonucleotide-directed mutagenesis (ODM) 21 May 2015 Obtained through Freedom of

Information request by CEO

BVL Legal interpretation to DG SANTE 28 September 2015 Obtained through Freedom of Information request by CEO

DG SANTE Reply to Vlaams Instituut voor Biotechnologie (VIB) 9 July 2015 Obtained through Freedom of Information request by CEO (doc 24 a2d3)

Vlaams Instituut voor Biotechnologie (VIB) Letter to Mr Ladislav Miko (DG SANTE) 10 June 2015 Obtained through Freedom of Information request by

CEO

DG SANTE Reply to Vlaams Instituut voor Biotechnologie (VIB) 9 July 2015 Obtained through Freedom of Information request by CEO

Vlaams Instituut voor Biotechnologie (VIB) Email to DG SANTE 6 July 2015 Obtained through Freedom of Information request by CEO

VIB Fact series Een schimmelresistente aardappel voor Belgieuml December 2014

50

51

52

53

54

55

56

57

58

59

60

61

62

63

64

65

66

67

68

69

70

71

72

73

74

Food and agriculture

Attached files Attached files

1_briefing_visit_keygenepdf

6pdf

13_presentation_at_esa_-_15-10-2012pdf

14_briefing_visit_nl_dg_2pdf

26_letter_from_fi_registered_versionpdf

30_bto_meeting_with_nbpt-2_registered_versionpdf

34_reply_to_finland_25-4-2014_registered_versionpdf

36_nbt_platform_multilateral_meeting_25_06_2014_steering_note_registered_versionpdf

42_e-mail_dow_agro_to_jrc_-_10-4-2012pdf

431_presentation_cnudde_31-5-2012pdf

44_bto_meeting_31-5-2012pdf

45_proposed_agenda_meeting_22-6-2012pdf

462_ppt_schouten_22-6-2012pdf

51_e-mail_nbt_platform_31-5-2013pdf

511_legal_briefing_paper_-_28-5-2013pdf

512_summary_legal_paper_22-5-2013pdf

513_nbt_factsheetspdf

53_e-mail_from_dow_agro_to_sanco_2-7-2013pdf

54_internal_e-mail_dg_sanco_8-7-2013pdf

561_esa_position_paper_-_fev_2014pdf

57_invitation_to_the_meeting_on_the_future_of_plant_nbts_in_the_eu_25_06_2014pdf

nbt_platform_multilateral_meeting_ares20144089348_-_signed_version_-_third_batchpdf

9pdf

6pdf

12pdf

18pdf

17_20150610_vib_letter_redactedpdf

18_20150615_lettre_autorites_competentes_redactedpdf

21_20150702_reply_to_nbtp-redactedpdf

24_20150709_reply_to_vib_redactedpdf

27_20150722_vib_redactedpdf

28_bto_-_meeting_l_miko_with_new_breeding_technique_platform_-_27_april_2015_redactedpdf

atd_2015-5344_-_doct_2pdf

atd_2015-5344_-_doct_7pdf

atd_2015-5344_-_doct_8pdf

ares20155217184annex-ms_non_paperpdf

httpwwwvibbenleducatieDocumentsVIB_dossier_20schimmelresistent

EASAC Statement on New Breeding Techniques July 2015 httpwwweasaceufileadminPDF_sreports_statementsEasac_14_NBTpdf

EASAC Planting the Future - opportunities and challenges for using crop genetic improvement technologies for sustainable agriculture June 2013

httpwwweasaceufileadminReportsPlanting_the_FutureEASAC_Planting

However one third of the working group are also member of PRRI an industry-minded lobby group of public scientists

Corporate Europe Observatory PRRI - Are these public researchers 2008 httpcorporateeuropeorgfood-and-agriculture200806prri-are-these-p

European Parliament Committee on Agriculture Hearing on ldquoNew Techniques for Plant Breedingrdquo 1 December 2015

httpspolcmssecureeuroparleuropaeucmsdatauploadd35d2641-ab77-49

Furthermore Schuttelaar amp Partners now lists only one client (Grodan a supplier to the horticulture sector) This is in sharp contrast to the lobby firmrsquos

own website where 11 clients from the food and biotech sectors are listed as examples of ldquocurrent and recent clientsrdquo

Schuttelaar amp Partners website As accessed 13 December 2015 httpwwwschuttelaar-partnerscomclients

EU Transparency Register website As accessed 15 November 2015 (No longer in public domain available from CEO)

EU Transparency Register Accessed 16 January 2016

Dorotheacutee Andreacutee DG SANTE Comment at EP Agriculture Committee hearing 1 December 2015

75

76

77

78

79

80

81

0

14_09-28_letter_de_redactedpdf

Tag Tag

genetically modified crops

GMOs

Belgian showfield of DutchGM DuRPhpotatoes

Related Latest

REPORT

Of apples and potatoesthe Dutch lobby for thederegulation ofcisgenesisFEBRUARY 2ND 2016 THE POWER OF

LOBBIES FOOD AND AGRICULTURE

The voice of the Dutch Government has been

loud and clear in Brussels on the issue of

cisgenic plants The Dutch have waged a

sustained campaign to have new GM

techniques ndash and in particular cisgenesis ndash

excluded from EU GMO regulations Several

Dutch ministries the Dutch Parliament the

Dutch Permanent Representation in Brussels

and Dutch MEPs have energetically pursued

this goal

STORY

Canadian company railroads EUdecision-making on new GM

FEBRUARY 2ND 2016 THE POWER OF LOBBIES FOOD AND

AGRICULTURE

At least one developer of new GM crops ndash

Canadian-based Cibus ndash has attempted to

bypass the European policy process by

presenting policy makers with a fait accompli

decisions by individual Member States on the

regulatory status of new techniques as well as

prematurely-launched trials of new GM crops

STORY

EU review of weedkillerglyphosate adds secrecyto controversy

JANUARY 14TH 2016 EFSA FOOD AND AGRICULTURE

More than 80 per cent of the national experts

involved in the EUs official assessment of

glyphosate refused to have their names

disclosed to the public

STORY

Solutions COP21Climate SmartAgriculture boostingthe technofix

DECEMBER 10TH 2015 CLIMATE AND ENERGY FOOD AND

AGRICULTURE

ldquoIf you like greenwashing clap your handsrdquo

1 of 321 of 32 next rsaquo

Corporate Europe Observatory

(CEO) is a research and campaign

group working to expose and

challenge the privileged access

and influence enjoyed by

corporations and their lobby

groups in EU policy making

Read more

CEO relies on grants and

donations to carry out our

research and campaign work By

making a donation or becoming a

friend of CEO you help to

support our efforts to expose

corporate lobbying increase

transparency and urge greater

democratic accountabililty in the

EU

Or

All written content on this

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Creative Commons Attribution-

NonCommercial-ShareAlike 30

Unported License

Page 6: FOROEUROPA - Biotech lobby’s push for new GMOs to escape … · 2016-02-04 · With respect to cisgenesis and intragenesis, EFSA concluded that while intragenic plants would generate

Trade concerns (1) avoiding disruptions at all costs

In lobbying the Commission DG Trade was not left out In a first

meeting in March 2012 Schuttelaar amp Partners raised their clientsrsquo

concerns about ldquothe legislative uncertaintyrdquo for new GM

techniques and added that in this field ldquothe EU occupies the

second place in the world for patent applications with the UK and

the Netherlands contributing most significantlyrdquo In late May

2012 Schuttelaar amp Partners staged a second larger meeting

attended by DG SANCO DG Trade and ldquoNBT Platform membersrdquo

Dow Agrosciences VIB KeyGene Syngenta Bayer CropScience

Rothamsted Research Rijk Zwaan and Wageningen University

Their message did not fall upon deaf ears After the first meeting a

DG Trade official concluded that his DG would ldquohave to ensure

that any measuresolution proposed will not result in trade

disruptionsrdquo And furthermore he reported ldquoI was reassured by my

SANCO counterparts that the trade angle will be taken into

account when deciding on the Commissionrsquos line to takerdquo

The European Seed Association announced to DG SANCO that it

wanted new GM techniques deregulated and specifically attacked

the EU traceability and labelling requirements for their ldquopotential

to hamper free traderdquo

its piegravece de reacutesistance the industryrsquos own lsquolegal interpretationrsquo of

the regulatory status of new GM techniques This was based on

a sort of questionnaire consisting of seven main questions (and

many subquestions) that it is explained must all be answered in

the affirmative in order for a product to be regulated as a GMO

This methodology was carefully designed to ensure the desired

outcome that all of the new GM techniques in question should

be unregulated and by extension untested and unlabelled

Source NBT Platform website

Question 3 and 4 aim to twist the definition of a GMO in EU Directive 200118 which is ldquoan organism with the exception of

human beings in which the genetic material has been altered in a way that does not occur naturally by mating andor natural

recombinationrdquo Using industrys methodology most of the new techniques would escape regulation as they can provide a negative

answer to one of these two questions The Platform analysis also argues that some of the new GM techniques are simply a

variation of mutagenesis (a technique that had long been in use when Directive 200118 was developed and that was explicitly

excluded from its scope) Furthermore the industry approach aims to undermine the process-based nature of the Directive as

described earlier

The arguments put forward by the NBT Platform are at the core of industrys rationale for the deregulation of new GM These

points or variations on them can also be found in lobby documents produced by the European Seed Association (ESA) the

European Plant Science Organisation (EPSO) the pesticide lobby group Croplife International and the Flemish biotech research

institute VIB

The pro-deregulation interpretation of the scope of Europersquos GM laws has been met with wide-ranging criticism Counter-

arguments have been provided by German federal agencies (for example the opinion by Professor Tade Matthias Spranger for BfN

the German Federal Agency of Nature Conservation) a legal analysis by Professor Ludwig Kraumlmer as commissioned by German civil

society and assessments by Greenpeace farming and other environmental groups Similarly industryrsquos attempt to have new GM

49

50

51

52

53

54

55

declared safe by design and therefore exempt from regulatory risk assessment has been countered by the Austrian Environmental

Agency and various non-governmental organisations

The legal case that new GM techniques should be covered by the current regulations is in fact crystal clear

The central purpose of Directive 200118 on the deliberate release of GMOs is to protect human health and the environment from

the release of genetically modified organisms The Directive clearly provides for the advent of new GM techniques which rely upon

in vitro methods to directly modify genomes These are the very type of techniques that EU law covers with its process-based

approach (where the technique used decides if the regulations apply) That process-based regulation and the precautionary

approach that lies at the heart of the directive are justified because of the unintended and unexpected effects of both GM 10 and

GM 20 techniques Techniques that have been developed since 2001 (or that didnt have any commercial application prior to 2001)

cannot be regarded as industry argues the same as traditional mutagenesis techniques that were exempted on the grounds of a

claimed history of safe use when the EU regulations were introduced

The key arguments from industry and counter-arguments are summarised in the following table

Table Key industry arguments for the deregulation of new GM techniques

Industry argument Response

1 ldquoNew GM is just l ike traditional plant1 ldquoNew GM is just l ike traditional plant

breedingrdquobreedingrdquo

Products from new GM are just like traditionally bred

plants since ldquono foreign DNA is usedrdquo Industry seeks to

reframe the legal interpretation of a GMO in this way

because many of the new techniques do not necessarily

use DNA from another species or use genetic material

other than DNA

In EU law a GMO does not need to contain foreign DNA to qualifyIn EU law a GMO does not need to contain foreign DNA to qualify

as a GMOas a GMO

The Directive refers to ldquoan organism hellipin which genetic material has been

altered in a way that does not occur naturally by mating andor natural

recombinationrdquo The new techniques directly modify an organismrsquos genetic

material without involving mating and are therefore genetic engineering In

addition the Directive also qualifies the introduction of other types of genetic

material than DNA as GM

2 ldquoJust because a GM technique is used does2 ldquoJust because a GM technique is used does

not mean that the product is legally a GMOrdquonot mean that the product is legally a GMOrdquo

If there is no GM material present in the final product

it should not be treated as a GMO This is an attack on

the process-based (technique-based) nature of the

Directive and would mean that products of several

methods that do involve GM would be exempt

The EU has The EU has recognisedrecognised that the GM that the GM technique usedtechnique used to to changechange an an

organisms organisms does does mattermatter

Itrsquos the genetic engineering process that can lead to unintentional alterations

of the genetic material giving rise to concerns regarding food and

environmental safety These concerns remain even if the genetic engineering

agent is subsequently removed

3 ldquoGene editing techniques are a form of3 ldquoGene editing techniques are a form of

mutagenesis rdquomutagenesis rdquo

Mutagenesis is excluded from the scope of the

Directive as it was assumed to have a history of safe

use

New gene editing techniques are different and have no histor y ofNew gene editing techniques are different and have no histor y of

safe usesafe use

They are different from the mutagenesis techniques (chemical and radiation)

referred to in the Directive

4 ldquoNew GM is safe by designrdquo4 ldquoNew GM is safe by designrdquo

The claim is that the genetic interventions are precise

and targeted and therefore safe This is reflected by the

terms used gene or genome editing

New GM techniques can have multiple unintended and unexpectedNew GM techniques can have multiple unintended and unexpected

results results

New GM methods pose very similar types of risks as GM 10 and should be

regulated at minimum in the same way as existing GMOs in order to protect

the environment and public health Precision in changing the genetic makeup

of an organism does not equate safety if you do not fully understand the

impacts

5 ldquoDetection is impossiblerdquo5 ldquoDetection is impossiblerdquo

Industry claims that detection methods will not be able

Detection methods are evolving as are genetic engineeringDetection methods are evolving as are genetic engineering

techniques techniques

56 57

Trade concerns (2) TTIP kicks in

Another line of argument pursued by the NBT Platform is the

comparison of how new GM techniques are regulated ndash or not ndash in

other parts of the world cumulating in the suggestion that a

stronger level of regulation in the EU will create trade barriers

In the context of TTIP the way the US deals with the new

techniques is of particular interest For example US-based

multinational Dow informed DG SANCO in 2013 of the decision by

the US Department of Agriculture (USDA) to not regulate Dows

ZFN-1 maize The Commission later reflected however that the

US Food and Drug Administration (FDA) ldquoremains rather vaguerdquo on

the issue It should be noted that the US hardly regulates GMOs

as such There are no formal data requirements when it comes to

safety testing and biotech companies voluntarily provide whatever

information they please

Emails released by the Commission provide evidence that the (de-

)regulation of new GM techniques was indeed discussed in a March

2014 TTIP-related meeting in Washington Despite repeated claims

at the time by the Commission that ldquoGM is not on the tablerdquo US

and EU authorities sat together with seed industry lobby groups

from both sides of the Atlantic (including the European Seed

Association)

to tell the difference between a new GM and a

traditionally-bred product

While distinguishing some new GM products from non-GM products may

currently be difficult this is very likely to change in the future

6 ldquoApplication of the precautionar y principle6 ldquoApplication of the precautionar y principle

should be reconsideredrdquoshould be reconsideredrdquo

Industry claims that since there is less uncertainty

related to new gene editing techniques than with

mutagenesis using radiation or chemical mutagens and

since the precautionary principle is about uncertainty it

should not be applied to new GM techniques

Precautionar y principle should be respectedPrecautionar y principle should be respected

The precautionary principle and the process-orientated approach to risk

assessment as established under EU law can only be implemented if the new

methods are covered by the Directive

5 Last phase lobbying

The third phase of the industry campaign indicated in the graph by lsquoPoliticsPublic Affairsrsquo (read Lobby) kicked in with a so-

called multi-stakeholder meeting held on 25 June 2014 lsquoThe future of plant breeding techniques in the European Unionrsquo was a

co-production of the NBT Platform and the industry-driven European Technology Platform Plants for the Future However the

NBT Platform cast a narrow net when inviting lsquostakeholdersrsquo on its list were the Member States Competent Authorities the

Commission and companies and their lobby associations (eg the European Seed Association farming lobby Copa-Cogeca and so

forth) Absent were environmental and consumer NGOs sustainable farming organisations and the like

The industry campaign escalated during this phase with dire predictions of economic collapse and job losses following the

eventual regulation of new GM According to the NBT Platform multi-stakeholder meeting report for example industrial farming

group Copa-Cogeca said that ldquooverly strictrdquo regulation would ldquoincrease unfair competitionrdquo for farmers In turn the European Plant

Science Organisation (EPSO) insisted that the current legal uncertainty was causing ldquointelligence leakagerdquo and destroying jobs

while another participant went as far as to warn that this ambiguity would lead to the ldquocomplete extinctionrdquo of a large part of the

plant breeding sector in Europe

By the start of 2015 the Commission appeared close to reaching

a decision on new GM techniques and things were starting to

heat up

In the spring the German Government decided to take matters

into its own hands It determined that Cibus ODM oilseed rape

did not qualify as a GMO so that field trialling could proceed

with no regulation or monitoring In response the Commission

quickly sent letters to Germany and all EU member states asking

them to ldquoawait as much as possible the outcome of the

Commission legal interpretation before authorising a deliberate

release of organisms obtained with new plant breeding

techniquesrdquo since ldquothe deliberate release of products which are

subject to the rules of the EU GMO legislation without

appropriate prior authorisation is illegalrdquo (See case study

Canadian company railroads EU decision making on new GM)

But Cibus also informed the Commission that as its product was

already being grown in the US ldquothe harvested material is used

like any other crop and likely entering the international

commodity chainrdquo According to the company the possibility of

this unauthorised GM oilseed rape being imported into the EU

could therefore not be excluded

Following the May 2014 elections a new Commissioner in charge

of DG SANTE (previously called SANCO) was installed the

Lithuanian Vytenis Andriukaitis The NBT Platform set the

58

59

60

61

62

63

64

65

66

necessary liaison efforts into motion and set up a meeting that took place in July 2015 The Platform also shifted focus to liaise

and gather information from EU member states and sought a meeting with the Commission (DGs SANTE AGRI and Trade) to

report back on these contacts

Furthermore at two occasions in 2015 GM developers got assistance from certain member states that have also been peddling a

pro-deregulation agenda with Brussels In May 2015 a lsquonon-paperrsquo authored by Germany the UK Ireland and Spain argued for the

deregulation of the ODM technique in particular using the same arguments as put forth by industry to argue that ldquoODM is a

variation of mutagenesisrdquo

In September the German food safety agency BVL in a joint exercise with its UK and Irish colleagues sent an interpretation of the

definition of a GMO in Directive 200118 to the Commission This document precisely echoes the industry discourse that a

product should only be regulated under EU GMO laws if it is produced by a GM process and if the result is a product that could

not have been achieved in a lsquonaturalrsquo way

Flemish biotechnology institute (VIB) and EASAC join the chorus

In this last phase corporate-backed research institutes like the Flemish VIB also stepped up their efforts in order to defend their

commercial interests On 5 June 2015 the VIB met with the Commission to discuss a number of new techniques Although the list

has not been disclosed following freedom of information requests according to the VIB ldquo the examples given represent concrete

business opportunities and vulnerable information from the viewpoint of competitionrdquo It appears likely from the Commission response

and a related email exchange on the topic that the VIB is eyeing cisgenesis and certain gene editing techniques VIB has an obvious

commercial interest in the deregulation of cisgenesis after having put its money on turning the failed Dutch cisgenic potato into a

Belgian specialty a blight-resistant Bintje a well known potato variety widely used for the countrys famous fries

Moreover in a remarkable statement addressed to the Commission in July 2015 the European Academies Science Advisory Council

(EASAC) also backed industrys views Their political demands dovetail with those of industry GMOs should be allowed to escape

regulation ldquowhen they do not contain foreign DNArdquo that GM products should be regulated only by trait and not technique and that the

use of the precautionary principle in GM regulation should be reconsidered The statement is based on the conclusions of an earlier

EASAC report Planting the Future This report was composed by a working group of experts acting in individual capacity nominated

by member academies of EASAC

Meanwhile in the European Parliament some MEPs unsuccessfully demanded a formal say in the process Others including Jan

Huitema (Liberals) and Anthea McIntyre (Conservatives) authored resolutions that included calls for the deregulation of new GM

techniques On 1 December 2015 a hearing took place in the European Parliament Agriculture Committee Edwin Hecker a NBT

Platform lobbyist and an employee of Schuttelaar amp Partners (although the latter was not disclosed) presented industrys views

again overstating the role of SMEs

Surprisingly only one week later the NBT Platform was deleted from Schuttelaar amp Partners list of clients in the register However

the information in the NBT Platforms entry and on its website remains unchanged (See box Does the NBT Platform still exist)

Does the NBT Platform still exist

Schuttelaar amp Partners made some remarkable changes to their registry entry on 7 December 2015 The NBT Platform has been deleted

as a client from the lobby groups entry This is contradictory as the NBT Platformrsquos entry is unchanged and still lists Mr Hecker as its

chair In line with this change the Commissions legal interpretation of Directive 200118 for the new GM techniques has been deleted

from the list of EU initiatives followed by the company

In addition the companys overall lobby-related expenses have been reduced tenfold from euro100000-500000 down to euro50000-99000

The consultancy now declares just a 08 FTE workload for lobbying activities This is at odds for instance with the fact that ten

employees currently hold lobby passes for the European Parliament

6 The Commissions interpretation Whose interests will prevail

All invested parties are now awaiting the Commissions decision to be presented in March 2016 Will the NBT Platform be

celebrating victory after achieving its Phase 4 Agreement goal Or will concerned governments NGOs and sustainable farming

67

68

69

70 71

72 73

74

75

76

77

78

79

80

organisations be relieved that the new GM technologies will be subject to the existing hard-won regulation

Maybe neither DG SANTE has already publicly stated that ldquosome will be pleased others disappointedrdquo indicating that at least

one perhaps more but not all of the new techniques will escape regulation as a result of the Commission decision If true this

would ndash no matter how many techniques are concerned ndash be a serious attack on food and environmental safety consumer choice

and transparency in the food chain as well as enhancing corporate concentration in the seed sector through patents

As Brussels itself realises the Commission release is probably just the beginning ndash and not the resolution ndash of this contentious

issue In all likelihood it will be the European Court of Justice that ultimately determines the regulatory fate of new GM

techniques The court case brought by environmental and farming organisations against Cibus ODM oilseed rape will therefore be

of great importance

In the meantime neither the biotech industry nor its financiers are likely to have the certainty they have been striving for

Furthermore other actors may still come into play Food distributors may demand direct liability for new GM products to those

who put them on the market And parliaments may insist on the labelling of new GM products like has happened in the

Netherlands The TTIP negotiations on the other hand may become a force against a proper regulation of GM 20 Environmental

and sustainable farming groups will have to remain on high alert

81

- Eckerstorfer M et al Environmental Agency Austria Technical report New plant breeding techniques and risks associated with their application 2014

httpwwwumweltbundesamtatfileadminsitepublikationenREP0477pd

- Kraumlmer L Legal questions concerning new methods for changing the genetic conditions in plants Legal analysis commissioned by Arbeitsgemeinschaft

baumluerliche Landwirtschaft (AbL) Bund fuumlr Umwelt und Naturschutz (BUND) etc September 2015

httpwwwtestbiotechorgsitesdefaultfilesKraemer_Legal20questions

- Spranger TM Legal Analysis of the applicability of Directive 200118EC on genome editing technologies Commissioned by the German Federal Agency

for Nature Conservation October 2015 httpbfndefileadminBfNagrogentechnikDokumenteLegal_analysis_of_g

Steinbrecher Ricarda Genetic Engineering in plants and the ldquoNew Breeding Techniques (NBTs)rdquo December 2015

httpwwweconexusinfopublicationgenetic-engineering-plants-and-new-

Corporate Europe Observatory and Inf OGM TTIP released emails show biotech seeds on the trade talks table 2 July 2015

httpcorporateeuropeorgfood-and-agriculture201507ttip-released-em

The Working Group was made up of two experts nominated from each member state Its final report was completed in 2012 but was never officially

published

See for a description of the techniques and reasons why they should be regulated Steinbrecher Ricarda Genetic Engineering in plants and the ldquoNew

Breeding Techniques (NBTs)rdquo December 2015 httpwwweconexusinfopublicationgenetic-engineering-plants-and-new-

Testbiotech Gene-editing and plants amp animals used in food production some technical socio-economic and legal aspects Backgrounder for Hearing on

ldquoNew Techniques for Plant Breedingrdquo in the EP Agriculture Committee 1 December 2015

httpwwwtestbiotechorgsitesdefaultfilesLegal20and20technical2

Waltz Emily Tiptoeing around Transgenics In Nature Biotechnology volume 30 number 3 March 2012

NBT Platform Fact sheet New Breeding Techniques Seizing the opportunity Version 2013

The Commission prioritised these techniques specifically since they entail ldquothe introduction of exogenous [that is lsquoforeignrsquo] genetic material into the

host which is the case for these techniques as it is for transgenesisrdquo

DG SANCO Steering note for NBT Platform meeting ldquoThe future of plant breeding techniques in the European Union 25 June 2014 Obtained through

Freedom of Information request by CEO

Several additional pieces of analysis were allocated to the Commissions Joint Research Centre (JRC)

EFSA Scientific opinion addressing the safety assessment of plants developed using cisgenesis and intragenesis 2012

httpwwwefsaeuropaeufrefsajournalpub2561

DG SANCO Background brief at the occasion of visit Mr Ladislav Miko to Keygene 26 January 2012 Obtained through Freedom of Information request

by CEO

DG SANCO Presentation on New Breeding Techniques at European Seed Association Annual Meeting 15 October 2012 Obtained through Freedom of

Information request by CEO

DG SANTE Email to NBT Platform 02 July 2015 Obtained through Freedom of Information request by CEO

European Parliament Follow up to the European Parliament resolution on ldquoPlant breeding what options to increase quality and yieldsrdquo (EP reference

number A7-00442014 P7_TA-PROV(2014)0131) 28 May 2014

BASF Letter to DEFRA 29 April 2013 Obtained through Freedom of Information request by GeneWatch

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

Finnish Board of Gene Technology Letter to Paolo Testori Coggi Director-General of DG SANCO 17 February 2014 Obtained through Freedom of

Information request by CEO

DG SANCO Letter to Finnish Board for Gene Technology 25 April 2014 Obtained through Freedom of Information request by CEO

NBT Platform two-pager April 2015 httpwwwnbtplatformorgbackground-documentsfactsheets2-pager-nbt-p

Bussink Michiel De strategie in Nederland Geen slapende honden wakker maken In Milieudefensie Magazine 1999-3

RTRS website Accessed 10 December 2015 httpwwwresponsiblesoyorgabout-rtrsgovernancetask-forcestask-for

Corporate Europe Observatory Roundtable on Responsible Soya - The certifying smokescreen 22 May 2012

httpcorporateeuropeorgsitesdefaultfilespublicationsrtrs_briefin

DG Trade Report from meeting with NBT Platform 07 June 2012 Obtained by Freedom of Information request by CEO

European Seed Association Position paper New Breeding Techniques ndash ensuring Progress and Diversity in Plant Breeding July 2012

httpswwweuroseedseusystemfilespublicationsfilesesa_1204462pdf

NBT Platform Fact sheet New Breeding Techniques Seizing the opportunity Version 2013

Cnudde F Dow Agrosciences Presentation Use of Zinc Finger Nucleases for plant breeding purposes May 2012 Obtained through Freedom of

Information request by CEO

Steinbrecher Ricarda Genetic Engineering in plants and the ldquoNew Breeding Techniques (NBTs)rdquo December 2015

httpwwweconexusinfopublicationgenetic-engineering-plants-and-new-

- httpswwwgrainorgesarticleentries588-gm-soybean-latin-america-s-

- httpslasojamatanetfilesparaguay-humanrights-reportpdf

Testbiotech Gene-editing and plants amp animals used in food production some technical socio-economic and legal aspects Backgrounder for Hearing on

ldquoNew Techniques for Plant Breedingrdquo in the EP Agriculture Committee 1 December 2015

httpwwwtestbiotechorgsitesdefaultfilesLegal20and20technical2

Fagan J Antoniou M Robinson C Earth Open Source GMO Myths and Truths 2014 httpgmomythsandtruthsearthopensourceorg

Greenpeace Twenty years of failure Why GM crops have failed to deliver on their promises November 2015

httpwwwgreenpeaceorginternationalGlobalinternationalpublication

NBT Platform two-pager April 2015 httpwwwnbtplatformorgbackground-documentsfactsheets2-pager-nbt-p

NBT Platform Email to DG Trade 18 May 2015 Obtained through Freedom of Information request by CEO Doc 2 A2D Trade

NBT Platform two-pager April 2015 httpwwwnbtplatformorgbackground-documentsfactsheets2-pager-nbt-p

EU Transparency Register Accessed 11 January 2016 httpeceuropaeutransparencyregisterpublicconsultationdisplaylobb

The lobbying activities covered by the register include all those that are ldquocarried out with the objective of directly or indirectly influencing the

formulation or implementation of policy and the decision-making processes of the EU institutions irrespective of where they are undertaken and of the

channel or medium of communication used for example via outsourcing media contracts with professional intermediaries think tanks platforms

forums campaigns and grassroots initiativesrdquo Article 7 httpeur-lexeuropaeulegal-contentENTXTHTMLuri=CELEX32014Q0919

Website NBT Platform Accessed 8 November 2015 Compared to a list provided in 2014 two members dropped off Cellectis Plant Sciences and Centre

RampD Nestleacute Tours httpwwwnbtplatformorg

DG SANCO Steering note for Mr Ladislav Miko at the occasion of a visit by Mr Hugo von Meijenfeldt Acting DG Environment Environment Ministry

Netherlands 15 November 2012

DG Trade Report from meeting with NBT Platform 07 June 2012 Obtained by Freedom of Information request by CEO

Inova Fruit is owned by five shareholders all large fruit auction companies 49 of shares are owned for instance by the Greenery that has over 1400

employees

For example Rothamsted Research website As accessed 11 January 2016 httpwwwrothamstedacuknewsnew-collaborative-research-project-gets

VIB website As accessed 21 December 2015 httpwwwvibbenlover-viborganisatiePaginasAlgemene-vergaderingaspx

ENERGYPOPLAR website As accessed 21 December 2015 httpwwwenergypoplareuinstitutionsphpid=40

NBT Platform two-pager April 2015 httpwwwnbtplatformorgbackground-documentsfactsheets2-pager-nbt-p

DG SANCO Notes of meeting with NBT Platform of 31 May 2012 06 June 2012 Obtained through Freedom of Information request by CEO

NBT Platform Proposed agenda for meeting on 22 June 2012 Obtained through Freedom of Information request by CEO

Schouten Henk Wageningen University and Research Center and Inova Fruit Presentation to European Commission Legal arguments to keep plants

from novel breeding techniques such as cisgenesis outside the GMO regulation 22 June 2012 Obtained through Freedom of Information request by CEO

Kempen F C Jung Genetic Modification of Plants Agriculture Horticulture and Forestry 2010 In Biotechnology in Agriculture and Forestry Springer

httpelibrarycomngUploadFilesfile0_10097pdf

Schuttelaar amp Partners was also hired for this project to draw up a communication plan ldquofor the acceptance and marketingrdquo of the cisgenic apple

National Academic Research and Collaborations Information System website As accessed 12 January 2016

httpwwwnarcisnlresearchRecordIDOND1310571

NBT Platform Email to DG SANCO 10 July 2012 Obtained through Freedom of Information request by CEO

17

18

19

20

21

22

23

24

25

26

27

28

29

30

31

32

33

34

35

36

37

38

39

40

41

42

43

44

45

46

47

48

49

DG Trade Report from meeting with NBT Platform 07 June 2012 Obtained through Freedom of Information request by CEO

DG Trade Report from meeting with Schuttelaar amp Partners on new breeding techniques 15 March 2012 Obtained through Freedom of Information

request by CEO

European Seed Association (ESA) Position paper Promoting and Enabling Innovation in Plant Breeding February 2014 Obtained through Freedom of

Information request by CEO

NBT Platform Legal Briefing Paper The regulatory status of plants resulting from New Breeding Technologies Version of 28 May 2013 Obtained

through Freedom of Information request by CEO

NBT Platform Summary of Legal Briefing Paper ldquoThe regulatory status of plants resulting fromNew Breeding Technologiesrdquo Obtained through Freedom

of Information request by CEO 22 May 2013 doc 512

The Directive 200118 (Annex 1B) lists two techniques ndash cell fusion and mutagenesis ndash for which an exemption has been granted and that are therefore

excluded from its scope As these two techniques predated the Directive by many years EU authorities assumed there was a lsquohistory of safe usersquo

The following documents exemplify the pro-deregulation arguments Each uses one or more of the points listed in the table

- European Technology Platform Plants for the Future Position paper New Breeding Techniques - Ensuring an Innovative and Diversified European

Agriculture September 2012 httpwwwepsoweborgfile1096

- European Seed Association Regulatory approaches to modern plant breeding - the case of mutagenesis and new gene editing technologies 20 July 2015

httpswwweuroseedseusystemfilespublicationsfilesesa_150543_0pdf

- CropLife International Position Paper Regulatory oversight of products developed through new breeding techniques 2014 httpscroplifeorgwp-

contentuploadspdf_filesRegulatory-Oversight-o

- NBT Platform Factsheet Oligonucleotide-Directed Mutagenesis accelerating innovation 2013 httpwwwnbtplatformorgbackground-

documentsfactsheetsfactsheet-oli

- NBT Platform Legal Briefing Paper The regulatory status of plants resulting from New Breeding Technologies Version of 28 May 2013

- Kraumlmer L Legal questions concerning new methods for changing the genetic conditions in plants Legal analysis commissioned by Arbeitsgemeinschaft

baumluerliche Landwirtschaft (AbL) Bund fuumlr Umwelt und Naturschutz (BUND) etc September 2015

httpwwwtestbiotechorgsitesdefaultfilesKraemer_Legal20questions

- Spranger TM Legal Analysis of the applicability of Directive 200118EC on genome editing technologies Commissioned by the German Federal Agency

for Nature Conservation October 2015 httpbfndefileadminBfNagrogentechnikDokumenteLegal_analysis_of_g

- Cotter J Zimmermann D Van Bekkem H Greenpeace Applications of the EU and Cartagena definitions of a GMO to the classification of plants

developed by cisgenesis and gene-editing techniques 2015 httpwwwgreenpeacetogreenpeacewp-contentuploads201511Applicati

- Reseau Semences Paysannes Confederation Paysanne et al Statut juridique des produits issus des nouvelles techniques de modification geacuteneacutetique des

plantes

DG SANCO Notes from meeting with NBT Platform 21 March 2014 Obtained through Freedom of Information request by CEO

NBT Platform and ETP Plants for the Future Meeting report Multilateral meeting lsquothe future of plant breeding techniques in the European Unionrsquo

Obtained through Freedom of Information request by CEO 25 June 2014

Ibid

Dow Agrosciences and DG SANCOJRC Emails April 2012 and July 2013 Obtained through Freedom of Information request by CEO

DG SANCO Internal email 8 July 2013 Obtained through Freedom of Information request by CEO

Corporate Europe Observatory and Inf OGM TTIP released emails show biotech seeds on the trade talks table 2 July 2015

httpcorporateeuropeorgfood-and-agriculture201507ttip-released-em

European Commission Letter to Competent Authorities 5 June 2015 Obtained through Freedom of Information request by CEO

Cibus Europe Letter to DG SANCO January 2015 Obtained through Freedom of Information request by CEO

Schuttelaar amp Partners Letter to Commissioner Vytenis Andriukaitis 1 December 2014 Obtained through Freedom of Information request by CEO

NBT Platform Email to Mr Ladislav Miko (DG SANTE) 26 February 2015 Obtained through Freedom of Information request by CEO

NBT Platform Email to DG Trade 18 May 2015 Obtained through Freedom of Information request by CEO

According to Agrafacts the non-paper was authored by German UK Irish and Spanish authorities

Non-paper on the regulatory status of plants generated by oligonucleotide-directed mutagenesis (ODM) 21 May 2015 Obtained through Freedom of

Information request by CEO

BVL Legal interpretation to DG SANTE 28 September 2015 Obtained through Freedom of Information request by CEO

DG SANTE Reply to Vlaams Instituut voor Biotechnologie (VIB) 9 July 2015 Obtained through Freedom of Information request by CEO (doc 24 a2d3)

Vlaams Instituut voor Biotechnologie (VIB) Letter to Mr Ladislav Miko (DG SANTE) 10 June 2015 Obtained through Freedom of Information request by

CEO

DG SANTE Reply to Vlaams Instituut voor Biotechnologie (VIB) 9 July 2015 Obtained through Freedom of Information request by CEO

Vlaams Instituut voor Biotechnologie (VIB) Email to DG SANTE 6 July 2015 Obtained through Freedom of Information request by CEO

VIB Fact series Een schimmelresistente aardappel voor Belgieuml December 2014

50

51

52

53

54

55

56

57

58

59

60

61

62

63

64

65

66

67

68

69

70

71

72

73

74

Food and agriculture

Attached files Attached files

1_briefing_visit_keygenepdf

6pdf

13_presentation_at_esa_-_15-10-2012pdf

14_briefing_visit_nl_dg_2pdf

26_letter_from_fi_registered_versionpdf

30_bto_meeting_with_nbpt-2_registered_versionpdf

34_reply_to_finland_25-4-2014_registered_versionpdf

36_nbt_platform_multilateral_meeting_25_06_2014_steering_note_registered_versionpdf

42_e-mail_dow_agro_to_jrc_-_10-4-2012pdf

431_presentation_cnudde_31-5-2012pdf

44_bto_meeting_31-5-2012pdf

45_proposed_agenda_meeting_22-6-2012pdf

462_ppt_schouten_22-6-2012pdf

51_e-mail_nbt_platform_31-5-2013pdf

511_legal_briefing_paper_-_28-5-2013pdf

512_summary_legal_paper_22-5-2013pdf

513_nbt_factsheetspdf

53_e-mail_from_dow_agro_to_sanco_2-7-2013pdf

54_internal_e-mail_dg_sanco_8-7-2013pdf

561_esa_position_paper_-_fev_2014pdf

57_invitation_to_the_meeting_on_the_future_of_plant_nbts_in_the_eu_25_06_2014pdf

nbt_platform_multilateral_meeting_ares20144089348_-_signed_version_-_third_batchpdf

9pdf

6pdf

12pdf

18pdf

17_20150610_vib_letter_redactedpdf

18_20150615_lettre_autorites_competentes_redactedpdf

21_20150702_reply_to_nbtp-redactedpdf

24_20150709_reply_to_vib_redactedpdf

27_20150722_vib_redactedpdf

28_bto_-_meeting_l_miko_with_new_breeding_technique_platform_-_27_april_2015_redactedpdf

atd_2015-5344_-_doct_2pdf

atd_2015-5344_-_doct_7pdf

atd_2015-5344_-_doct_8pdf

ares20155217184annex-ms_non_paperpdf

httpwwwvibbenleducatieDocumentsVIB_dossier_20schimmelresistent

EASAC Statement on New Breeding Techniques July 2015 httpwwweasaceufileadminPDF_sreports_statementsEasac_14_NBTpdf

EASAC Planting the Future - opportunities and challenges for using crop genetic improvement technologies for sustainable agriculture June 2013

httpwwweasaceufileadminReportsPlanting_the_FutureEASAC_Planting

However one third of the working group are also member of PRRI an industry-minded lobby group of public scientists

Corporate Europe Observatory PRRI - Are these public researchers 2008 httpcorporateeuropeorgfood-and-agriculture200806prri-are-these-p

European Parliament Committee on Agriculture Hearing on ldquoNew Techniques for Plant Breedingrdquo 1 December 2015

httpspolcmssecureeuroparleuropaeucmsdatauploadd35d2641-ab77-49

Furthermore Schuttelaar amp Partners now lists only one client (Grodan a supplier to the horticulture sector) This is in sharp contrast to the lobby firmrsquos

own website where 11 clients from the food and biotech sectors are listed as examples of ldquocurrent and recent clientsrdquo

Schuttelaar amp Partners website As accessed 13 December 2015 httpwwwschuttelaar-partnerscomclients

EU Transparency Register website As accessed 15 November 2015 (No longer in public domain available from CEO)

EU Transparency Register Accessed 16 January 2016

Dorotheacutee Andreacutee DG SANTE Comment at EP Agriculture Committee hearing 1 December 2015

75

76

77

78

79

80

81

0

14_09-28_letter_de_redactedpdf

Tag Tag

genetically modified crops

GMOs

Belgian showfield of DutchGM DuRPhpotatoes

Related Latest

REPORT

Of apples and potatoesthe Dutch lobby for thederegulation ofcisgenesisFEBRUARY 2ND 2016 THE POWER OF

LOBBIES FOOD AND AGRICULTURE

The voice of the Dutch Government has been

loud and clear in Brussels on the issue of

cisgenic plants The Dutch have waged a

sustained campaign to have new GM

techniques ndash and in particular cisgenesis ndash

excluded from EU GMO regulations Several

Dutch ministries the Dutch Parliament the

Dutch Permanent Representation in Brussels

and Dutch MEPs have energetically pursued

this goal

STORY

Canadian company railroads EUdecision-making on new GM

FEBRUARY 2ND 2016 THE POWER OF LOBBIES FOOD AND

AGRICULTURE

At least one developer of new GM crops ndash

Canadian-based Cibus ndash has attempted to

bypass the European policy process by

presenting policy makers with a fait accompli

decisions by individual Member States on the

regulatory status of new techniques as well as

prematurely-launched trials of new GM crops

STORY

EU review of weedkillerglyphosate adds secrecyto controversy

JANUARY 14TH 2016 EFSA FOOD AND AGRICULTURE

More than 80 per cent of the national experts

involved in the EUs official assessment of

glyphosate refused to have their names

disclosed to the public

STORY

Solutions COP21Climate SmartAgriculture boostingthe technofix

DECEMBER 10TH 2015 CLIMATE AND ENERGY FOOD AND

AGRICULTURE

ldquoIf you like greenwashing clap your handsrdquo

1 of 321 of 32 next rsaquo

Corporate Europe Observatory

(CEO) is a research and campaign

group working to expose and

challenge the privileged access

and influence enjoyed by

corporations and their lobby

groups in EU policy making

Read more

CEO relies on grants and

donations to carry out our

research and campaign work By

making a donation or becoming a

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corporate lobbying increase

transparency and urge greater

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NonCommercial-ShareAlike 30

Unported License

Page 7: FOROEUROPA - Biotech lobby’s push for new GMOs to escape … · 2016-02-04 · With respect to cisgenesis and intragenesis, EFSA concluded that while intragenic plants would generate

declared safe by design and therefore exempt from regulatory risk assessment has been countered by the Austrian Environmental

Agency and various non-governmental organisations

The legal case that new GM techniques should be covered by the current regulations is in fact crystal clear

The central purpose of Directive 200118 on the deliberate release of GMOs is to protect human health and the environment from

the release of genetically modified organisms The Directive clearly provides for the advent of new GM techniques which rely upon

in vitro methods to directly modify genomes These are the very type of techniques that EU law covers with its process-based

approach (where the technique used decides if the regulations apply) That process-based regulation and the precautionary

approach that lies at the heart of the directive are justified because of the unintended and unexpected effects of both GM 10 and

GM 20 techniques Techniques that have been developed since 2001 (or that didnt have any commercial application prior to 2001)

cannot be regarded as industry argues the same as traditional mutagenesis techniques that were exempted on the grounds of a

claimed history of safe use when the EU regulations were introduced

The key arguments from industry and counter-arguments are summarised in the following table

Table Key industry arguments for the deregulation of new GM techniques

Industry argument Response

1 ldquoNew GM is just l ike traditional plant1 ldquoNew GM is just l ike traditional plant

breedingrdquobreedingrdquo

Products from new GM are just like traditionally bred

plants since ldquono foreign DNA is usedrdquo Industry seeks to

reframe the legal interpretation of a GMO in this way

because many of the new techniques do not necessarily

use DNA from another species or use genetic material

other than DNA

In EU law a GMO does not need to contain foreign DNA to qualifyIn EU law a GMO does not need to contain foreign DNA to qualify

as a GMOas a GMO

The Directive refers to ldquoan organism hellipin which genetic material has been

altered in a way that does not occur naturally by mating andor natural

recombinationrdquo The new techniques directly modify an organismrsquos genetic

material without involving mating and are therefore genetic engineering In

addition the Directive also qualifies the introduction of other types of genetic

material than DNA as GM

2 ldquoJust because a GM technique is used does2 ldquoJust because a GM technique is used does

not mean that the product is legally a GMOrdquonot mean that the product is legally a GMOrdquo

If there is no GM material present in the final product

it should not be treated as a GMO This is an attack on

the process-based (technique-based) nature of the

Directive and would mean that products of several

methods that do involve GM would be exempt

The EU has The EU has recognisedrecognised that the GM that the GM technique usedtechnique used to to changechange an an

organisms organisms does does mattermatter

Itrsquos the genetic engineering process that can lead to unintentional alterations

of the genetic material giving rise to concerns regarding food and

environmental safety These concerns remain even if the genetic engineering

agent is subsequently removed

3 ldquoGene editing techniques are a form of3 ldquoGene editing techniques are a form of

mutagenesis rdquomutagenesis rdquo

Mutagenesis is excluded from the scope of the

Directive as it was assumed to have a history of safe

use

New gene editing techniques are different and have no histor y ofNew gene editing techniques are different and have no histor y of

safe usesafe use

They are different from the mutagenesis techniques (chemical and radiation)

referred to in the Directive

4 ldquoNew GM is safe by designrdquo4 ldquoNew GM is safe by designrdquo

The claim is that the genetic interventions are precise

and targeted and therefore safe This is reflected by the

terms used gene or genome editing

New GM techniques can have multiple unintended and unexpectedNew GM techniques can have multiple unintended and unexpected

results results

New GM methods pose very similar types of risks as GM 10 and should be

regulated at minimum in the same way as existing GMOs in order to protect

the environment and public health Precision in changing the genetic makeup

of an organism does not equate safety if you do not fully understand the

impacts

5 ldquoDetection is impossiblerdquo5 ldquoDetection is impossiblerdquo

Industry claims that detection methods will not be able

Detection methods are evolving as are genetic engineeringDetection methods are evolving as are genetic engineering

techniques techniques

56 57

Trade concerns (2) TTIP kicks in

Another line of argument pursued by the NBT Platform is the

comparison of how new GM techniques are regulated ndash or not ndash in

other parts of the world cumulating in the suggestion that a

stronger level of regulation in the EU will create trade barriers

In the context of TTIP the way the US deals with the new

techniques is of particular interest For example US-based

multinational Dow informed DG SANCO in 2013 of the decision by

the US Department of Agriculture (USDA) to not regulate Dows

ZFN-1 maize The Commission later reflected however that the

US Food and Drug Administration (FDA) ldquoremains rather vaguerdquo on

the issue It should be noted that the US hardly regulates GMOs

as such There are no formal data requirements when it comes to

safety testing and biotech companies voluntarily provide whatever

information they please

Emails released by the Commission provide evidence that the (de-

)regulation of new GM techniques was indeed discussed in a March

2014 TTIP-related meeting in Washington Despite repeated claims

at the time by the Commission that ldquoGM is not on the tablerdquo US

and EU authorities sat together with seed industry lobby groups

from both sides of the Atlantic (including the European Seed

Association)

to tell the difference between a new GM and a

traditionally-bred product

While distinguishing some new GM products from non-GM products may

currently be difficult this is very likely to change in the future

6 ldquoApplication of the precautionar y principle6 ldquoApplication of the precautionar y principle

should be reconsideredrdquoshould be reconsideredrdquo

Industry claims that since there is less uncertainty

related to new gene editing techniques than with

mutagenesis using radiation or chemical mutagens and

since the precautionary principle is about uncertainty it

should not be applied to new GM techniques

Precautionar y principle should be respectedPrecautionar y principle should be respected

The precautionary principle and the process-orientated approach to risk

assessment as established under EU law can only be implemented if the new

methods are covered by the Directive

5 Last phase lobbying

The third phase of the industry campaign indicated in the graph by lsquoPoliticsPublic Affairsrsquo (read Lobby) kicked in with a so-

called multi-stakeholder meeting held on 25 June 2014 lsquoThe future of plant breeding techniques in the European Unionrsquo was a

co-production of the NBT Platform and the industry-driven European Technology Platform Plants for the Future However the

NBT Platform cast a narrow net when inviting lsquostakeholdersrsquo on its list were the Member States Competent Authorities the

Commission and companies and their lobby associations (eg the European Seed Association farming lobby Copa-Cogeca and so

forth) Absent were environmental and consumer NGOs sustainable farming organisations and the like

The industry campaign escalated during this phase with dire predictions of economic collapse and job losses following the

eventual regulation of new GM According to the NBT Platform multi-stakeholder meeting report for example industrial farming

group Copa-Cogeca said that ldquooverly strictrdquo regulation would ldquoincrease unfair competitionrdquo for farmers In turn the European Plant

Science Organisation (EPSO) insisted that the current legal uncertainty was causing ldquointelligence leakagerdquo and destroying jobs

while another participant went as far as to warn that this ambiguity would lead to the ldquocomplete extinctionrdquo of a large part of the

plant breeding sector in Europe

By the start of 2015 the Commission appeared close to reaching

a decision on new GM techniques and things were starting to

heat up

In the spring the German Government decided to take matters

into its own hands It determined that Cibus ODM oilseed rape

did not qualify as a GMO so that field trialling could proceed

with no regulation or monitoring In response the Commission

quickly sent letters to Germany and all EU member states asking

them to ldquoawait as much as possible the outcome of the

Commission legal interpretation before authorising a deliberate

release of organisms obtained with new plant breeding

techniquesrdquo since ldquothe deliberate release of products which are

subject to the rules of the EU GMO legislation without

appropriate prior authorisation is illegalrdquo (See case study

Canadian company railroads EU decision making on new GM)

But Cibus also informed the Commission that as its product was

already being grown in the US ldquothe harvested material is used

like any other crop and likely entering the international

commodity chainrdquo According to the company the possibility of

this unauthorised GM oilseed rape being imported into the EU

could therefore not be excluded

Following the May 2014 elections a new Commissioner in charge

of DG SANTE (previously called SANCO) was installed the

Lithuanian Vytenis Andriukaitis The NBT Platform set the

58

59

60

61

62

63

64

65

66

necessary liaison efforts into motion and set up a meeting that took place in July 2015 The Platform also shifted focus to liaise

and gather information from EU member states and sought a meeting with the Commission (DGs SANTE AGRI and Trade) to

report back on these contacts

Furthermore at two occasions in 2015 GM developers got assistance from certain member states that have also been peddling a

pro-deregulation agenda with Brussels In May 2015 a lsquonon-paperrsquo authored by Germany the UK Ireland and Spain argued for the

deregulation of the ODM technique in particular using the same arguments as put forth by industry to argue that ldquoODM is a

variation of mutagenesisrdquo

In September the German food safety agency BVL in a joint exercise with its UK and Irish colleagues sent an interpretation of the

definition of a GMO in Directive 200118 to the Commission This document precisely echoes the industry discourse that a

product should only be regulated under EU GMO laws if it is produced by a GM process and if the result is a product that could

not have been achieved in a lsquonaturalrsquo way

Flemish biotechnology institute (VIB) and EASAC join the chorus

In this last phase corporate-backed research institutes like the Flemish VIB also stepped up their efforts in order to defend their

commercial interests On 5 June 2015 the VIB met with the Commission to discuss a number of new techniques Although the list

has not been disclosed following freedom of information requests according to the VIB ldquo the examples given represent concrete

business opportunities and vulnerable information from the viewpoint of competitionrdquo It appears likely from the Commission response

and a related email exchange on the topic that the VIB is eyeing cisgenesis and certain gene editing techniques VIB has an obvious

commercial interest in the deregulation of cisgenesis after having put its money on turning the failed Dutch cisgenic potato into a

Belgian specialty a blight-resistant Bintje a well known potato variety widely used for the countrys famous fries

Moreover in a remarkable statement addressed to the Commission in July 2015 the European Academies Science Advisory Council

(EASAC) also backed industrys views Their political demands dovetail with those of industry GMOs should be allowed to escape

regulation ldquowhen they do not contain foreign DNArdquo that GM products should be regulated only by trait and not technique and that the

use of the precautionary principle in GM regulation should be reconsidered The statement is based on the conclusions of an earlier

EASAC report Planting the Future This report was composed by a working group of experts acting in individual capacity nominated

by member academies of EASAC

Meanwhile in the European Parliament some MEPs unsuccessfully demanded a formal say in the process Others including Jan

Huitema (Liberals) and Anthea McIntyre (Conservatives) authored resolutions that included calls for the deregulation of new GM

techniques On 1 December 2015 a hearing took place in the European Parliament Agriculture Committee Edwin Hecker a NBT

Platform lobbyist and an employee of Schuttelaar amp Partners (although the latter was not disclosed) presented industrys views

again overstating the role of SMEs

Surprisingly only one week later the NBT Platform was deleted from Schuttelaar amp Partners list of clients in the register However

the information in the NBT Platforms entry and on its website remains unchanged (See box Does the NBT Platform still exist)

Does the NBT Platform still exist

Schuttelaar amp Partners made some remarkable changes to their registry entry on 7 December 2015 The NBT Platform has been deleted

as a client from the lobby groups entry This is contradictory as the NBT Platformrsquos entry is unchanged and still lists Mr Hecker as its

chair In line with this change the Commissions legal interpretation of Directive 200118 for the new GM techniques has been deleted

from the list of EU initiatives followed by the company

In addition the companys overall lobby-related expenses have been reduced tenfold from euro100000-500000 down to euro50000-99000

The consultancy now declares just a 08 FTE workload for lobbying activities This is at odds for instance with the fact that ten

employees currently hold lobby passes for the European Parliament

6 The Commissions interpretation Whose interests will prevail

All invested parties are now awaiting the Commissions decision to be presented in March 2016 Will the NBT Platform be

celebrating victory after achieving its Phase 4 Agreement goal Or will concerned governments NGOs and sustainable farming

67

68

69

70 71

72 73

74

75

76

77

78

79

80

organisations be relieved that the new GM technologies will be subject to the existing hard-won regulation

Maybe neither DG SANTE has already publicly stated that ldquosome will be pleased others disappointedrdquo indicating that at least

one perhaps more but not all of the new techniques will escape regulation as a result of the Commission decision If true this

would ndash no matter how many techniques are concerned ndash be a serious attack on food and environmental safety consumer choice

and transparency in the food chain as well as enhancing corporate concentration in the seed sector through patents

As Brussels itself realises the Commission release is probably just the beginning ndash and not the resolution ndash of this contentious

issue In all likelihood it will be the European Court of Justice that ultimately determines the regulatory fate of new GM

techniques The court case brought by environmental and farming organisations against Cibus ODM oilseed rape will therefore be

of great importance

In the meantime neither the biotech industry nor its financiers are likely to have the certainty they have been striving for

Furthermore other actors may still come into play Food distributors may demand direct liability for new GM products to those

who put them on the market And parliaments may insist on the labelling of new GM products like has happened in the

Netherlands The TTIP negotiations on the other hand may become a force against a proper regulation of GM 20 Environmental

and sustainable farming groups will have to remain on high alert

81

- Eckerstorfer M et al Environmental Agency Austria Technical report New plant breeding techniques and risks associated with their application 2014

httpwwwumweltbundesamtatfileadminsitepublikationenREP0477pd

- Kraumlmer L Legal questions concerning new methods for changing the genetic conditions in plants Legal analysis commissioned by Arbeitsgemeinschaft

baumluerliche Landwirtschaft (AbL) Bund fuumlr Umwelt und Naturschutz (BUND) etc September 2015

httpwwwtestbiotechorgsitesdefaultfilesKraemer_Legal20questions

- Spranger TM Legal Analysis of the applicability of Directive 200118EC on genome editing technologies Commissioned by the German Federal Agency

for Nature Conservation October 2015 httpbfndefileadminBfNagrogentechnikDokumenteLegal_analysis_of_g

Steinbrecher Ricarda Genetic Engineering in plants and the ldquoNew Breeding Techniques (NBTs)rdquo December 2015

httpwwweconexusinfopublicationgenetic-engineering-plants-and-new-

Corporate Europe Observatory and Inf OGM TTIP released emails show biotech seeds on the trade talks table 2 July 2015

httpcorporateeuropeorgfood-and-agriculture201507ttip-released-em

The Working Group was made up of two experts nominated from each member state Its final report was completed in 2012 but was never officially

published

See for a description of the techniques and reasons why they should be regulated Steinbrecher Ricarda Genetic Engineering in plants and the ldquoNew

Breeding Techniques (NBTs)rdquo December 2015 httpwwweconexusinfopublicationgenetic-engineering-plants-and-new-

Testbiotech Gene-editing and plants amp animals used in food production some technical socio-economic and legal aspects Backgrounder for Hearing on

ldquoNew Techniques for Plant Breedingrdquo in the EP Agriculture Committee 1 December 2015

httpwwwtestbiotechorgsitesdefaultfilesLegal20and20technical2

Waltz Emily Tiptoeing around Transgenics In Nature Biotechnology volume 30 number 3 March 2012

NBT Platform Fact sheet New Breeding Techniques Seizing the opportunity Version 2013

The Commission prioritised these techniques specifically since they entail ldquothe introduction of exogenous [that is lsquoforeignrsquo] genetic material into the

host which is the case for these techniques as it is for transgenesisrdquo

DG SANCO Steering note for NBT Platform meeting ldquoThe future of plant breeding techniques in the European Union 25 June 2014 Obtained through

Freedom of Information request by CEO

Several additional pieces of analysis were allocated to the Commissions Joint Research Centre (JRC)

EFSA Scientific opinion addressing the safety assessment of plants developed using cisgenesis and intragenesis 2012

httpwwwefsaeuropaeufrefsajournalpub2561

DG SANCO Background brief at the occasion of visit Mr Ladislav Miko to Keygene 26 January 2012 Obtained through Freedom of Information request

by CEO

DG SANCO Presentation on New Breeding Techniques at European Seed Association Annual Meeting 15 October 2012 Obtained through Freedom of

Information request by CEO

DG SANTE Email to NBT Platform 02 July 2015 Obtained through Freedom of Information request by CEO

European Parliament Follow up to the European Parliament resolution on ldquoPlant breeding what options to increase quality and yieldsrdquo (EP reference

number A7-00442014 P7_TA-PROV(2014)0131) 28 May 2014

BASF Letter to DEFRA 29 April 2013 Obtained through Freedom of Information request by GeneWatch

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

Finnish Board of Gene Technology Letter to Paolo Testori Coggi Director-General of DG SANCO 17 February 2014 Obtained through Freedom of

Information request by CEO

DG SANCO Letter to Finnish Board for Gene Technology 25 April 2014 Obtained through Freedom of Information request by CEO

NBT Platform two-pager April 2015 httpwwwnbtplatformorgbackground-documentsfactsheets2-pager-nbt-p

Bussink Michiel De strategie in Nederland Geen slapende honden wakker maken In Milieudefensie Magazine 1999-3

RTRS website Accessed 10 December 2015 httpwwwresponsiblesoyorgabout-rtrsgovernancetask-forcestask-for

Corporate Europe Observatory Roundtable on Responsible Soya - The certifying smokescreen 22 May 2012

httpcorporateeuropeorgsitesdefaultfilespublicationsrtrs_briefin

DG Trade Report from meeting with NBT Platform 07 June 2012 Obtained by Freedom of Information request by CEO

European Seed Association Position paper New Breeding Techniques ndash ensuring Progress and Diversity in Plant Breeding July 2012

httpswwweuroseedseusystemfilespublicationsfilesesa_1204462pdf

NBT Platform Fact sheet New Breeding Techniques Seizing the opportunity Version 2013

Cnudde F Dow Agrosciences Presentation Use of Zinc Finger Nucleases for plant breeding purposes May 2012 Obtained through Freedom of

Information request by CEO

Steinbrecher Ricarda Genetic Engineering in plants and the ldquoNew Breeding Techniques (NBTs)rdquo December 2015

httpwwweconexusinfopublicationgenetic-engineering-plants-and-new-

- httpswwwgrainorgesarticleentries588-gm-soybean-latin-america-s-

- httpslasojamatanetfilesparaguay-humanrights-reportpdf

Testbiotech Gene-editing and plants amp animals used in food production some technical socio-economic and legal aspects Backgrounder for Hearing on

ldquoNew Techniques for Plant Breedingrdquo in the EP Agriculture Committee 1 December 2015

httpwwwtestbiotechorgsitesdefaultfilesLegal20and20technical2

Fagan J Antoniou M Robinson C Earth Open Source GMO Myths and Truths 2014 httpgmomythsandtruthsearthopensourceorg

Greenpeace Twenty years of failure Why GM crops have failed to deliver on their promises November 2015

httpwwwgreenpeaceorginternationalGlobalinternationalpublication

NBT Platform two-pager April 2015 httpwwwnbtplatformorgbackground-documentsfactsheets2-pager-nbt-p

NBT Platform Email to DG Trade 18 May 2015 Obtained through Freedom of Information request by CEO Doc 2 A2D Trade

NBT Platform two-pager April 2015 httpwwwnbtplatformorgbackground-documentsfactsheets2-pager-nbt-p

EU Transparency Register Accessed 11 January 2016 httpeceuropaeutransparencyregisterpublicconsultationdisplaylobb

The lobbying activities covered by the register include all those that are ldquocarried out with the objective of directly or indirectly influencing the

formulation or implementation of policy and the decision-making processes of the EU institutions irrespective of where they are undertaken and of the

channel or medium of communication used for example via outsourcing media contracts with professional intermediaries think tanks platforms

forums campaigns and grassroots initiativesrdquo Article 7 httpeur-lexeuropaeulegal-contentENTXTHTMLuri=CELEX32014Q0919

Website NBT Platform Accessed 8 November 2015 Compared to a list provided in 2014 two members dropped off Cellectis Plant Sciences and Centre

RampD Nestleacute Tours httpwwwnbtplatformorg

DG SANCO Steering note for Mr Ladislav Miko at the occasion of a visit by Mr Hugo von Meijenfeldt Acting DG Environment Environment Ministry

Netherlands 15 November 2012

DG Trade Report from meeting with NBT Platform 07 June 2012 Obtained by Freedom of Information request by CEO

Inova Fruit is owned by five shareholders all large fruit auction companies 49 of shares are owned for instance by the Greenery that has over 1400

employees

For example Rothamsted Research website As accessed 11 January 2016 httpwwwrothamstedacuknewsnew-collaborative-research-project-gets

VIB website As accessed 21 December 2015 httpwwwvibbenlover-viborganisatiePaginasAlgemene-vergaderingaspx

ENERGYPOPLAR website As accessed 21 December 2015 httpwwwenergypoplareuinstitutionsphpid=40

NBT Platform two-pager April 2015 httpwwwnbtplatformorgbackground-documentsfactsheets2-pager-nbt-p

DG SANCO Notes of meeting with NBT Platform of 31 May 2012 06 June 2012 Obtained through Freedom of Information request by CEO

NBT Platform Proposed agenda for meeting on 22 June 2012 Obtained through Freedom of Information request by CEO

Schouten Henk Wageningen University and Research Center and Inova Fruit Presentation to European Commission Legal arguments to keep plants

from novel breeding techniques such as cisgenesis outside the GMO regulation 22 June 2012 Obtained through Freedom of Information request by CEO

Kempen F C Jung Genetic Modification of Plants Agriculture Horticulture and Forestry 2010 In Biotechnology in Agriculture and Forestry Springer

httpelibrarycomngUploadFilesfile0_10097pdf

Schuttelaar amp Partners was also hired for this project to draw up a communication plan ldquofor the acceptance and marketingrdquo of the cisgenic apple

National Academic Research and Collaborations Information System website As accessed 12 January 2016

httpwwwnarcisnlresearchRecordIDOND1310571

NBT Platform Email to DG SANCO 10 July 2012 Obtained through Freedom of Information request by CEO

17

18

19

20

21

22

23

24

25

26

27

28

29

30

31

32

33

34

35

36

37

38

39

40

41

42

43

44

45

46

47

48

49

DG Trade Report from meeting with NBT Platform 07 June 2012 Obtained through Freedom of Information request by CEO

DG Trade Report from meeting with Schuttelaar amp Partners on new breeding techniques 15 March 2012 Obtained through Freedom of Information

request by CEO

European Seed Association (ESA) Position paper Promoting and Enabling Innovation in Plant Breeding February 2014 Obtained through Freedom of

Information request by CEO

NBT Platform Legal Briefing Paper The regulatory status of plants resulting from New Breeding Technologies Version of 28 May 2013 Obtained

through Freedom of Information request by CEO

NBT Platform Summary of Legal Briefing Paper ldquoThe regulatory status of plants resulting fromNew Breeding Technologiesrdquo Obtained through Freedom

of Information request by CEO 22 May 2013 doc 512

The Directive 200118 (Annex 1B) lists two techniques ndash cell fusion and mutagenesis ndash for which an exemption has been granted and that are therefore

excluded from its scope As these two techniques predated the Directive by many years EU authorities assumed there was a lsquohistory of safe usersquo

The following documents exemplify the pro-deregulation arguments Each uses one or more of the points listed in the table

- European Technology Platform Plants for the Future Position paper New Breeding Techniques - Ensuring an Innovative and Diversified European

Agriculture September 2012 httpwwwepsoweborgfile1096

- European Seed Association Regulatory approaches to modern plant breeding - the case of mutagenesis and new gene editing technologies 20 July 2015

httpswwweuroseedseusystemfilespublicationsfilesesa_150543_0pdf

- CropLife International Position Paper Regulatory oversight of products developed through new breeding techniques 2014 httpscroplifeorgwp-

contentuploadspdf_filesRegulatory-Oversight-o

- NBT Platform Factsheet Oligonucleotide-Directed Mutagenesis accelerating innovation 2013 httpwwwnbtplatformorgbackground-

documentsfactsheetsfactsheet-oli

- NBT Platform Legal Briefing Paper The regulatory status of plants resulting from New Breeding Technologies Version of 28 May 2013

- Kraumlmer L Legal questions concerning new methods for changing the genetic conditions in plants Legal analysis commissioned by Arbeitsgemeinschaft

baumluerliche Landwirtschaft (AbL) Bund fuumlr Umwelt und Naturschutz (BUND) etc September 2015

httpwwwtestbiotechorgsitesdefaultfilesKraemer_Legal20questions

- Spranger TM Legal Analysis of the applicability of Directive 200118EC on genome editing technologies Commissioned by the German Federal Agency

for Nature Conservation October 2015 httpbfndefileadminBfNagrogentechnikDokumenteLegal_analysis_of_g

- Cotter J Zimmermann D Van Bekkem H Greenpeace Applications of the EU and Cartagena definitions of a GMO to the classification of plants

developed by cisgenesis and gene-editing techniques 2015 httpwwwgreenpeacetogreenpeacewp-contentuploads201511Applicati

- Reseau Semences Paysannes Confederation Paysanne et al Statut juridique des produits issus des nouvelles techniques de modification geacuteneacutetique des

plantes

DG SANCO Notes from meeting with NBT Platform 21 March 2014 Obtained through Freedom of Information request by CEO

NBT Platform and ETP Plants for the Future Meeting report Multilateral meeting lsquothe future of plant breeding techniques in the European Unionrsquo

Obtained through Freedom of Information request by CEO 25 June 2014

Ibid

Dow Agrosciences and DG SANCOJRC Emails April 2012 and July 2013 Obtained through Freedom of Information request by CEO

DG SANCO Internal email 8 July 2013 Obtained through Freedom of Information request by CEO

Corporate Europe Observatory and Inf OGM TTIP released emails show biotech seeds on the trade talks table 2 July 2015

httpcorporateeuropeorgfood-and-agriculture201507ttip-released-em

European Commission Letter to Competent Authorities 5 June 2015 Obtained through Freedom of Information request by CEO

Cibus Europe Letter to DG SANCO January 2015 Obtained through Freedom of Information request by CEO

Schuttelaar amp Partners Letter to Commissioner Vytenis Andriukaitis 1 December 2014 Obtained through Freedom of Information request by CEO

NBT Platform Email to Mr Ladislav Miko (DG SANTE) 26 February 2015 Obtained through Freedom of Information request by CEO

NBT Platform Email to DG Trade 18 May 2015 Obtained through Freedom of Information request by CEO

According to Agrafacts the non-paper was authored by German UK Irish and Spanish authorities

Non-paper on the regulatory status of plants generated by oligonucleotide-directed mutagenesis (ODM) 21 May 2015 Obtained through Freedom of

Information request by CEO

BVL Legal interpretation to DG SANTE 28 September 2015 Obtained through Freedom of Information request by CEO

DG SANTE Reply to Vlaams Instituut voor Biotechnologie (VIB) 9 July 2015 Obtained through Freedom of Information request by CEO (doc 24 a2d3)

Vlaams Instituut voor Biotechnologie (VIB) Letter to Mr Ladislav Miko (DG SANTE) 10 June 2015 Obtained through Freedom of Information request by

CEO

DG SANTE Reply to Vlaams Instituut voor Biotechnologie (VIB) 9 July 2015 Obtained through Freedom of Information request by CEO

Vlaams Instituut voor Biotechnologie (VIB) Email to DG SANTE 6 July 2015 Obtained through Freedom of Information request by CEO

VIB Fact series Een schimmelresistente aardappel voor Belgieuml December 2014

50

51

52

53

54

55

56

57

58

59

60

61

62

63

64

65

66

67

68

69

70

71

72

73

74

Food and agriculture

Attached files Attached files

1_briefing_visit_keygenepdf

6pdf

13_presentation_at_esa_-_15-10-2012pdf

14_briefing_visit_nl_dg_2pdf

26_letter_from_fi_registered_versionpdf

30_bto_meeting_with_nbpt-2_registered_versionpdf

34_reply_to_finland_25-4-2014_registered_versionpdf

36_nbt_platform_multilateral_meeting_25_06_2014_steering_note_registered_versionpdf

42_e-mail_dow_agro_to_jrc_-_10-4-2012pdf

431_presentation_cnudde_31-5-2012pdf

44_bto_meeting_31-5-2012pdf

45_proposed_agenda_meeting_22-6-2012pdf

462_ppt_schouten_22-6-2012pdf

51_e-mail_nbt_platform_31-5-2013pdf

511_legal_briefing_paper_-_28-5-2013pdf

512_summary_legal_paper_22-5-2013pdf

513_nbt_factsheetspdf

53_e-mail_from_dow_agro_to_sanco_2-7-2013pdf

54_internal_e-mail_dg_sanco_8-7-2013pdf

561_esa_position_paper_-_fev_2014pdf

57_invitation_to_the_meeting_on_the_future_of_plant_nbts_in_the_eu_25_06_2014pdf

nbt_platform_multilateral_meeting_ares20144089348_-_signed_version_-_third_batchpdf

9pdf

6pdf

12pdf

18pdf

17_20150610_vib_letter_redactedpdf

18_20150615_lettre_autorites_competentes_redactedpdf

21_20150702_reply_to_nbtp-redactedpdf

24_20150709_reply_to_vib_redactedpdf

27_20150722_vib_redactedpdf

28_bto_-_meeting_l_miko_with_new_breeding_technique_platform_-_27_april_2015_redactedpdf

atd_2015-5344_-_doct_2pdf

atd_2015-5344_-_doct_7pdf

atd_2015-5344_-_doct_8pdf

ares20155217184annex-ms_non_paperpdf

httpwwwvibbenleducatieDocumentsVIB_dossier_20schimmelresistent

EASAC Statement on New Breeding Techniques July 2015 httpwwweasaceufileadminPDF_sreports_statementsEasac_14_NBTpdf

EASAC Planting the Future - opportunities and challenges for using crop genetic improvement technologies for sustainable agriculture June 2013

httpwwweasaceufileadminReportsPlanting_the_FutureEASAC_Planting

However one third of the working group are also member of PRRI an industry-minded lobby group of public scientists

Corporate Europe Observatory PRRI - Are these public researchers 2008 httpcorporateeuropeorgfood-and-agriculture200806prri-are-these-p

European Parliament Committee on Agriculture Hearing on ldquoNew Techniques for Plant Breedingrdquo 1 December 2015

httpspolcmssecureeuroparleuropaeucmsdatauploadd35d2641-ab77-49

Furthermore Schuttelaar amp Partners now lists only one client (Grodan a supplier to the horticulture sector) This is in sharp contrast to the lobby firmrsquos

own website where 11 clients from the food and biotech sectors are listed as examples of ldquocurrent and recent clientsrdquo

Schuttelaar amp Partners website As accessed 13 December 2015 httpwwwschuttelaar-partnerscomclients

EU Transparency Register website As accessed 15 November 2015 (No longer in public domain available from CEO)

EU Transparency Register Accessed 16 January 2016

Dorotheacutee Andreacutee DG SANTE Comment at EP Agriculture Committee hearing 1 December 2015

75

76

77

78

79

80

81

0

14_09-28_letter_de_redactedpdf

Tag Tag

genetically modified crops

GMOs

Belgian showfield of DutchGM DuRPhpotatoes

Related Latest

REPORT

Of apples and potatoesthe Dutch lobby for thederegulation ofcisgenesisFEBRUARY 2ND 2016 THE POWER OF

LOBBIES FOOD AND AGRICULTURE

The voice of the Dutch Government has been

loud and clear in Brussels on the issue of

cisgenic plants The Dutch have waged a

sustained campaign to have new GM

techniques ndash and in particular cisgenesis ndash

excluded from EU GMO regulations Several

Dutch ministries the Dutch Parliament the

Dutch Permanent Representation in Brussels

and Dutch MEPs have energetically pursued

this goal

STORY

Canadian company railroads EUdecision-making on new GM

FEBRUARY 2ND 2016 THE POWER OF LOBBIES FOOD AND

AGRICULTURE

At least one developer of new GM crops ndash

Canadian-based Cibus ndash has attempted to

bypass the European policy process by

presenting policy makers with a fait accompli

decisions by individual Member States on the

regulatory status of new techniques as well as

prematurely-launched trials of new GM crops

STORY

EU review of weedkillerglyphosate adds secrecyto controversy

JANUARY 14TH 2016 EFSA FOOD AND AGRICULTURE

More than 80 per cent of the national experts

involved in the EUs official assessment of

glyphosate refused to have their names

disclosed to the public

STORY

Solutions COP21Climate SmartAgriculture boostingthe technofix

DECEMBER 10TH 2015 CLIMATE AND ENERGY FOOD AND

AGRICULTURE

ldquoIf you like greenwashing clap your handsrdquo

1 of 321 of 32 next rsaquo

Corporate Europe Observatory

(CEO) is a research and campaign

group working to expose and

challenge the privileged access

and influence enjoyed by

corporations and their lobby

groups in EU policy making

Read more

CEO relies on grants and

donations to carry out our

research and campaign work By

making a donation or becoming a

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NonCommercial-ShareAlike 30

Unported License

Page 8: FOROEUROPA - Biotech lobby’s push for new GMOs to escape … · 2016-02-04 · With respect to cisgenesis and intragenesis, EFSA concluded that while intragenic plants would generate

Trade concerns (2) TTIP kicks in

Another line of argument pursued by the NBT Platform is the

comparison of how new GM techniques are regulated ndash or not ndash in

other parts of the world cumulating in the suggestion that a

stronger level of regulation in the EU will create trade barriers

In the context of TTIP the way the US deals with the new

techniques is of particular interest For example US-based

multinational Dow informed DG SANCO in 2013 of the decision by

the US Department of Agriculture (USDA) to not regulate Dows

ZFN-1 maize The Commission later reflected however that the

US Food and Drug Administration (FDA) ldquoremains rather vaguerdquo on

the issue It should be noted that the US hardly regulates GMOs

as such There are no formal data requirements when it comes to

safety testing and biotech companies voluntarily provide whatever

information they please

Emails released by the Commission provide evidence that the (de-

)regulation of new GM techniques was indeed discussed in a March

2014 TTIP-related meeting in Washington Despite repeated claims

at the time by the Commission that ldquoGM is not on the tablerdquo US

and EU authorities sat together with seed industry lobby groups

from both sides of the Atlantic (including the European Seed

Association)

to tell the difference between a new GM and a

traditionally-bred product

While distinguishing some new GM products from non-GM products may

currently be difficult this is very likely to change in the future

6 ldquoApplication of the precautionar y principle6 ldquoApplication of the precautionar y principle

should be reconsideredrdquoshould be reconsideredrdquo

Industry claims that since there is less uncertainty

related to new gene editing techniques than with

mutagenesis using radiation or chemical mutagens and

since the precautionary principle is about uncertainty it

should not be applied to new GM techniques

Precautionar y principle should be respectedPrecautionar y principle should be respected

The precautionary principle and the process-orientated approach to risk

assessment as established under EU law can only be implemented if the new

methods are covered by the Directive

5 Last phase lobbying

The third phase of the industry campaign indicated in the graph by lsquoPoliticsPublic Affairsrsquo (read Lobby) kicked in with a so-

called multi-stakeholder meeting held on 25 June 2014 lsquoThe future of plant breeding techniques in the European Unionrsquo was a

co-production of the NBT Platform and the industry-driven European Technology Platform Plants for the Future However the

NBT Platform cast a narrow net when inviting lsquostakeholdersrsquo on its list were the Member States Competent Authorities the

Commission and companies and their lobby associations (eg the European Seed Association farming lobby Copa-Cogeca and so

forth) Absent were environmental and consumer NGOs sustainable farming organisations and the like

The industry campaign escalated during this phase with dire predictions of economic collapse and job losses following the

eventual regulation of new GM According to the NBT Platform multi-stakeholder meeting report for example industrial farming

group Copa-Cogeca said that ldquooverly strictrdquo regulation would ldquoincrease unfair competitionrdquo for farmers In turn the European Plant

Science Organisation (EPSO) insisted that the current legal uncertainty was causing ldquointelligence leakagerdquo and destroying jobs

while another participant went as far as to warn that this ambiguity would lead to the ldquocomplete extinctionrdquo of a large part of the

plant breeding sector in Europe

By the start of 2015 the Commission appeared close to reaching

a decision on new GM techniques and things were starting to

heat up

In the spring the German Government decided to take matters

into its own hands It determined that Cibus ODM oilseed rape

did not qualify as a GMO so that field trialling could proceed

with no regulation or monitoring In response the Commission

quickly sent letters to Germany and all EU member states asking

them to ldquoawait as much as possible the outcome of the

Commission legal interpretation before authorising a deliberate

release of organisms obtained with new plant breeding

techniquesrdquo since ldquothe deliberate release of products which are

subject to the rules of the EU GMO legislation without

appropriate prior authorisation is illegalrdquo (See case study

Canadian company railroads EU decision making on new GM)

But Cibus also informed the Commission that as its product was

already being grown in the US ldquothe harvested material is used

like any other crop and likely entering the international

commodity chainrdquo According to the company the possibility of

this unauthorised GM oilseed rape being imported into the EU

could therefore not be excluded

Following the May 2014 elections a new Commissioner in charge

of DG SANTE (previously called SANCO) was installed the

Lithuanian Vytenis Andriukaitis The NBT Platform set the

58

59

60

61

62

63

64

65

66

necessary liaison efforts into motion and set up a meeting that took place in July 2015 The Platform also shifted focus to liaise

and gather information from EU member states and sought a meeting with the Commission (DGs SANTE AGRI and Trade) to

report back on these contacts

Furthermore at two occasions in 2015 GM developers got assistance from certain member states that have also been peddling a

pro-deregulation agenda with Brussels In May 2015 a lsquonon-paperrsquo authored by Germany the UK Ireland and Spain argued for the

deregulation of the ODM technique in particular using the same arguments as put forth by industry to argue that ldquoODM is a

variation of mutagenesisrdquo

In September the German food safety agency BVL in a joint exercise with its UK and Irish colleagues sent an interpretation of the

definition of a GMO in Directive 200118 to the Commission This document precisely echoes the industry discourse that a

product should only be regulated under EU GMO laws if it is produced by a GM process and if the result is a product that could

not have been achieved in a lsquonaturalrsquo way

Flemish biotechnology institute (VIB) and EASAC join the chorus

In this last phase corporate-backed research institutes like the Flemish VIB also stepped up their efforts in order to defend their

commercial interests On 5 June 2015 the VIB met with the Commission to discuss a number of new techniques Although the list

has not been disclosed following freedom of information requests according to the VIB ldquo the examples given represent concrete

business opportunities and vulnerable information from the viewpoint of competitionrdquo It appears likely from the Commission response

and a related email exchange on the topic that the VIB is eyeing cisgenesis and certain gene editing techniques VIB has an obvious

commercial interest in the deregulation of cisgenesis after having put its money on turning the failed Dutch cisgenic potato into a

Belgian specialty a blight-resistant Bintje a well known potato variety widely used for the countrys famous fries

Moreover in a remarkable statement addressed to the Commission in July 2015 the European Academies Science Advisory Council

(EASAC) also backed industrys views Their political demands dovetail with those of industry GMOs should be allowed to escape

regulation ldquowhen they do not contain foreign DNArdquo that GM products should be regulated only by trait and not technique and that the

use of the precautionary principle in GM regulation should be reconsidered The statement is based on the conclusions of an earlier

EASAC report Planting the Future This report was composed by a working group of experts acting in individual capacity nominated

by member academies of EASAC

Meanwhile in the European Parliament some MEPs unsuccessfully demanded a formal say in the process Others including Jan

Huitema (Liberals) and Anthea McIntyre (Conservatives) authored resolutions that included calls for the deregulation of new GM

techniques On 1 December 2015 a hearing took place in the European Parliament Agriculture Committee Edwin Hecker a NBT

Platform lobbyist and an employee of Schuttelaar amp Partners (although the latter was not disclosed) presented industrys views

again overstating the role of SMEs

Surprisingly only one week later the NBT Platform was deleted from Schuttelaar amp Partners list of clients in the register However

the information in the NBT Platforms entry and on its website remains unchanged (See box Does the NBT Platform still exist)

Does the NBT Platform still exist

Schuttelaar amp Partners made some remarkable changes to their registry entry on 7 December 2015 The NBT Platform has been deleted

as a client from the lobby groups entry This is contradictory as the NBT Platformrsquos entry is unchanged and still lists Mr Hecker as its

chair In line with this change the Commissions legal interpretation of Directive 200118 for the new GM techniques has been deleted

from the list of EU initiatives followed by the company

In addition the companys overall lobby-related expenses have been reduced tenfold from euro100000-500000 down to euro50000-99000

The consultancy now declares just a 08 FTE workload for lobbying activities This is at odds for instance with the fact that ten

employees currently hold lobby passes for the European Parliament

6 The Commissions interpretation Whose interests will prevail

All invested parties are now awaiting the Commissions decision to be presented in March 2016 Will the NBT Platform be

celebrating victory after achieving its Phase 4 Agreement goal Or will concerned governments NGOs and sustainable farming

67

68

69

70 71

72 73

74

75

76

77

78

79

80

organisations be relieved that the new GM technologies will be subject to the existing hard-won regulation

Maybe neither DG SANTE has already publicly stated that ldquosome will be pleased others disappointedrdquo indicating that at least

one perhaps more but not all of the new techniques will escape regulation as a result of the Commission decision If true this

would ndash no matter how many techniques are concerned ndash be a serious attack on food and environmental safety consumer choice

and transparency in the food chain as well as enhancing corporate concentration in the seed sector through patents

As Brussels itself realises the Commission release is probably just the beginning ndash and not the resolution ndash of this contentious

issue In all likelihood it will be the European Court of Justice that ultimately determines the regulatory fate of new GM

techniques The court case brought by environmental and farming organisations against Cibus ODM oilseed rape will therefore be

of great importance

In the meantime neither the biotech industry nor its financiers are likely to have the certainty they have been striving for

Furthermore other actors may still come into play Food distributors may demand direct liability for new GM products to those

who put them on the market And parliaments may insist on the labelling of new GM products like has happened in the

Netherlands The TTIP negotiations on the other hand may become a force against a proper regulation of GM 20 Environmental

and sustainable farming groups will have to remain on high alert

81

- Eckerstorfer M et al Environmental Agency Austria Technical report New plant breeding techniques and risks associated with their application 2014

httpwwwumweltbundesamtatfileadminsitepublikationenREP0477pd

- Kraumlmer L Legal questions concerning new methods for changing the genetic conditions in plants Legal analysis commissioned by Arbeitsgemeinschaft

baumluerliche Landwirtschaft (AbL) Bund fuumlr Umwelt und Naturschutz (BUND) etc September 2015

httpwwwtestbiotechorgsitesdefaultfilesKraemer_Legal20questions

- Spranger TM Legal Analysis of the applicability of Directive 200118EC on genome editing technologies Commissioned by the German Federal Agency

for Nature Conservation October 2015 httpbfndefileadminBfNagrogentechnikDokumenteLegal_analysis_of_g

Steinbrecher Ricarda Genetic Engineering in plants and the ldquoNew Breeding Techniques (NBTs)rdquo December 2015

httpwwweconexusinfopublicationgenetic-engineering-plants-and-new-

Corporate Europe Observatory and Inf OGM TTIP released emails show biotech seeds on the trade talks table 2 July 2015

httpcorporateeuropeorgfood-and-agriculture201507ttip-released-em

The Working Group was made up of two experts nominated from each member state Its final report was completed in 2012 but was never officially

published

See for a description of the techniques and reasons why they should be regulated Steinbrecher Ricarda Genetic Engineering in plants and the ldquoNew

Breeding Techniques (NBTs)rdquo December 2015 httpwwweconexusinfopublicationgenetic-engineering-plants-and-new-

Testbiotech Gene-editing and plants amp animals used in food production some technical socio-economic and legal aspects Backgrounder for Hearing on

ldquoNew Techniques for Plant Breedingrdquo in the EP Agriculture Committee 1 December 2015

httpwwwtestbiotechorgsitesdefaultfilesLegal20and20technical2

Waltz Emily Tiptoeing around Transgenics In Nature Biotechnology volume 30 number 3 March 2012

NBT Platform Fact sheet New Breeding Techniques Seizing the opportunity Version 2013

The Commission prioritised these techniques specifically since they entail ldquothe introduction of exogenous [that is lsquoforeignrsquo] genetic material into the

host which is the case for these techniques as it is for transgenesisrdquo

DG SANCO Steering note for NBT Platform meeting ldquoThe future of plant breeding techniques in the European Union 25 June 2014 Obtained through

Freedom of Information request by CEO

Several additional pieces of analysis were allocated to the Commissions Joint Research Centre (JRC)

EFSA Scientific opinion addressing the safety assessment of plants developed using cisgenesis and intragenesis 2012

httpwwwefsaeuropaeufrefsajournalpub2561

DG SANCO Background brief at the occasion of visit Mr Ladislav Miko to Keygene 26 January 2012 Obtained through Freedom of Information request

by CEO

DG SANCO Presentation on New Breeding Techniques at European Seed Association Annual Meeting 15 October 2012 Obtained through Freedom of

Information request by CEO

DG SANTE Email to NBT Platform 02 July 2015 Obtained through Freedom of Information request by CEO

European Parliament Follow up to the European Parliament resolution on ldquoPlant breeding what options to increase quality and yieldsrdquo (EP reference

number A7-00442014 P7_TA-PROV(2014)0131) 28 May 2014

BASF Letter to DEFRA 29 April 2013 Obtained through Freedom of Information request by GeneWatch

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

Finnish Board of Gene Technology Letter to Paolo Testori Coggi Director-General of DG SANCO 17 February 2014 Obtained through Freedom of

Information request by CEO

DG SANCO Letter to Finnish Board for Gene Technology 25 April 2014 Obtained through Freedom of Information request by CEO

NBT Platform two-pager April 2015 httpwwwnbtplatformorgbackground-documentsfactsheets2-pager-nbt-p

Bussink Michiel De strategie in Nederland Geen slapende honden wakker maken In Milieudefensie Magazine 1999-3

RTRS website Accessed 10 December 2015 httpwwwresponsiblesoyorgabout-rtrsgovernancetask-forcestask-for

Corporate Europe Observatory Roundtable on Responsible Soya - The certifying smokescreen 22 May 2012

httpcorporateeuropeorgsitesdefaultfilespublicationsrtrs_briefin

DG Trade Report from meeting with NBT Platform 07 June 2012 Obtained by Freedom of Information request by CEO

European Seed Association Position paper New Breeding Techniques ndash ensuring Progress and Diversity in Plant Breeding July 2012

httpswwweuroseedseusystemfilespublicationsfilesesa_1204462pdf

NBT Platform Fact sheet New Breeding Techniques Seizing the opportunity Version 2013

Cnudde F Dow Agrosciences Presentation Use of Zinc Finger Nucleases for plant breeding purposes May 2012 Obtained through Freedom of

Information request by CEO

Steinbrecher Ricarda Genetic Engineering in plants and the ldquoNew Breeding Techniques (NBTs)rdquo December 2015

httpwwweconexusinfopublicationgenetic-engineering-plants-and-new-

- httpswwwgrainorgesarticleentries588-gm-soybean-latin-america-s-

- httpslasojamatanetfilesparaguay-humanrights-reportpdf

Testbiotech Gene-editing and plants amp animals used in food production some technical socio-economic and legal aspects Backgrounder for Hearing on

ldquoNew Techniques for Plant Breedingrdquo in the EP Agriculture Committee 1 December 2015

httpwwwtestbiotechorgsitesdefaultfilesLegal20and20technical2

Fagan J Antoniou M Robinson C Earth Open Source GMO Myths and Truths 2014 httpgmomythsandtruthsearthopensourceorg

Greenpeace Twenty years of failure Why GM crops have failed to deliver on their promises November 2015

httpwwwgreenpeaceorginternationalGlobalinternationalpublication

NBT Platform two-pager April 2015 httpwwwnbtplatformorgbackground-documentsfactsheets2-pager-nbt-p

NBT Platform Email to DG Trade 18 May 2015 Obtained through Freedom of Information request by CEO Doc 2 A2D Trade

NBT Platform two-pager April 2015 httpwwwnbtplatformorgbackground-documentsfactsheets2-pager-nbt-p

EU Transparency Register Accessed 11 January 2016 httpeceuropaeutransparencyregisterpublicconsultationdisplaylobb

The lobbying activities covered by the register include all those that are ldquocarried out with the objective of directly or indirectly influencing the

formulation or implementation of policy and the decision-making processes of the EU institutions irrespective of where they are undertaken and of the

channel or medium of communication used for example via outsourcing media contracts with professional intermediaries think tanks platforms

forums campaigns and grassroots initiativesrdquo Article 7 httpeur-lexeuropaeulegal-contentENTXTHTMLuri=CELEX32014Q0919

Website NBT Platform Accessed 8 November 2015 Compared to a list provided in 2014 two members dropped off Cellectis Plant Sciences and Centre

RampD Nestleacute Tours httpwwwnbtplatformorg

DG SANCO Steering note for Mr Ladislav Miko at the occasion of a visit by Mr Hugo von Meijenfeldt Acting DG Environment Environment Ministry

Netherlands 15 November 2012

DG Trade Report from meeting with NBT Platform 07 June 2012 Obtained by Freedom of Information request by CEO

Inova Fruit is owned by five shareholders all large fruit auction companies 49 of shares are owned for instance by the Greenery that has over 1400

employees

For example Rothamsted Research website As accessed 11 January 2016 httpwwwrothamstedacuknewsnew-collaborative-research-project-gets

VIB website As accessed 21 December 2015 httpwwwvibbenlover-viborganisatiePaginasAlgemene-vergaderingaspx

ENERGYPOPLAR website As accessed 21 December 2015 httpwwwenergypoplareuinstitutionsphpid=40

NBT Platform two-pager April 2015 httpwwwnbtplatformorgbackground-documentsfactsheets2-pager-nbt-p

DG SANCO Notes of meeting with NBT Platform of 31 May 2012 06 June 2012 Obtained through Freedom of Information request by CEO

NBT Platform Proposed agenda for meeting on 22 June 2012 Obtained through Freedom of Information request by CEO

Schouten Henk Wageningen University and Research Center and Inova Fruit Presentation to European Commission Legal arguments to keep plants

from novel breeding techniques such as cisgenesis outside the GMO regulation 22 June 2012 Obtained through Freedom of Information request by CEO

Kempen F C Jung Genetic Modification of Plants Agriculture Horticulture and Forestry 2010 In Biotechnology in Agriculture and Forestry Springer

httpelibrarycomngUploadFilesfile0_10097pdf

Schuttelaar amp Partners was also hired for this project to draw up a communication plan ldquofor the acceptance and marketingrdquo of the cisgenic apple

National Academic Research and Collaborations Information System website As accessed 12 January 2016

httpwwwnarcisnlresearchRecordIDOND1310571

NBT Platform Email to DG SANCO 10 July 2012 Obtained through Freedom of Information request by CEO

17

18

19

20

21

22

23

24

25

26

27

28

29

30

31

32

33

34

35

36

37

38

39

40

41

42

43

44

45

46

47

48

49

DG Trade Report from meeting with NBT Platform 07 June 2012 Obtained through Freedom of Information request by CEO

DG Trade Report from meeting with Schuttelaar amp Partners on new breeding techniques 15 March 2012 Obtained through Freedom of Information

request by CEO

European Seed Association (ESA) Position paper Promoting and Enabling Innovation in Plant Breeding February 2014 Obtained through Freedom of

Information request by CEO

NBT Platform Legal Briefing Paper The regulatory status of plants resulting from New Breeding Technologies Version of 28 May 2013 Obtained

through Freedom of Information request by CEO

NBT Platform Summary of Legal Briefing Paper ldquoThe regulatory status of plants resulting fromNew Breeding Technologiesrdquo Obtained through Freedom

of Information request by CEO 22 May 2013 doc 512

The Directive 200118 (Annex 1B) lists two techniques ndash cell fusion and mutagenesis ndash for which an exemption has been granted and that are therefore

excluded from its scope As these two techniques predated the Directive by many years EU authorities assumed there was a lsquohistory of safe usersquo

The following documents exemplify the pro-deregulation arguments Each uses one or more of the points listed in the table

- European Technology Platform Plants for the Future Position paper New Breeding Techniques - Ensuring an Innovative and Diversified European

Agriculture September 2012 httpwwwepsoweborgfile1096

- European Seed Association Regulatory approaches to modern plant breeding - the case of mutagenesis and new gene editing technologies 20 July 2015

httpswwweuroseedseusystemfilespublicationsfilesesa_150543_0pdf

- CropLife International Position Paper Regulatory oversight of products developed through new breeding techniques 2014 httpscroplifeorgwp-

contentuploadspdf_filesRegulatory-Oversight-o

- NBT Platform Factsheet Oligonucleotide-Directed Mutagenesis accelerating innovation 2013 httpwwwnbtplatformorgbackground-

documentsfactsheetsfactsheet-oli

- NBT Platform Legal Briefing Paper The regulatory status of plants resulting from New Breeding Technologies Version of 28 May 2013

- Kraumlmer L Legal questions concerning new methods for changing the genetic conditions in plants Legal analysis commissioned by Arbeitsgemeinschaft

baumluerliche Landwirtschaft (AbL) Bund fuumlr Umwelt und Naturschutz (BUND) etc September 2015

httpwwwtestbiotechorgsitesdefaultfilesKraemer_Legal20questions

- Spranger TM Legal Analysis of the applicability of Directive 200118EC on genome editing technologies Commissioned by the German Federal Agency

for Nature Conservation October 2015 httpbfndefileadminBfNagrogentechnikDokumenteLegal_analysis_of_g

- Cotter J Zimmermann D Van Bekkem H Greenpeace Applications of the EU and Cartagena definitions of a GMO to the classification of plants

developed by cisgenesis and gene-editing techniques 2015 httpwwwgreenpeacetogreenpeacewp-contentuploads201511Applicati

- Reseau Semences Paysannes Confederation Paysanne et al Statut juridique des produits issus des nouvelles techniques de modification geacuteneacutetique des

plantes

DG SANCO Notes from meeting with NBT Platform 21 March 2014 Obtained through Freedom of Information request by CEO

NBT Platform and ETP Plants for the Future Meeting report Multilateral meeting lsquothe future of plant breeding techniques in the European Unionrsquo

Obtained through Freedom of Information request by CEO 25 June 2014

Ibid

Dow Agrosciences and DG SANCOJRC Emails April 2012 and July 2013 Obtained through Freedom of Information request by CEO

DG SANCO Internal email 8 July 2013 Obtained through Freedom of Information request by CEO

Corporate Europe Observatory and Inf OGM TTIP released emails show biotech seeds on the trade talks table 2 July 2015

httpcorporateeuropeorgfood-and-agriculture201507ttip-released-em

European Commission Letter to Competent Authorities 5 June 2015 Obtained through Freedom of Information request by CEO

Cibus Europe Letter to DG SANCO January 2015 Obtained through Freedom of Information request by CEO

Schuttelaar amp Partners Letter to Commissioner Vytenis Andriukaitis 1 December 2014 Obtained through Freedom of Information request by CEO

NBT Platform Email to Mr Ladislav Miko (DG SANTE) 26 February 2015 Obtained through Freedom of Information request by CEO

NBT Platform Email to DG Trade 18 May 2015 Obtained through Freedom of Information request by CEO

According to Agrafacts the non-paper was authored by German UK Irish and Spanish authorities

Non-paper on the regulatory status of plants generated by oligonucleotide-directed mutagenesis (ODM) 21 May 2015 Obtained through Freedom of

Information request by CEO

BVL Legal interpretation to DG SANTE 28 September 2015 Obtained through Freedom of Information request by CEO

DG SANTE Reply to Vlaams Instituut voor Biotechnologie (VIB) 9 July 2015 Obtained through Freedom of Information request by CEO (doc 24 a2d3)

Vlaams Instituut voor Biotechnologie (VIB) Letter to Mr Ladislav Miko (DG SANTE) 10 June 2015 Obtained through Freedom of Information request by

CEO

DG SANTE Reply to Vlaams Instituut voor Biotechnologie (VIB) 9 July 2015 Obtained through Freedom of Information request by CEO

Vlaams Instituut voor Biotechnologie (VIB) Email to DG SANTE 6 July 2015 Obtained through Freedom of Information request by CEO

VIB Fact series Een schimmelresistente aardappel voor Belgieuml December 2014

50

51

52

53

54

55

56

57

58

59

60

61

62

63

64

65

66

67

68

69

70

71

72

73

74

Food and agriculture

Attached files Attached files

1_briefing_visit_keygenepdf

6pdf

13_presentation_at_esa_-_15-10-2012pdf

14_briefing_visit_nl_dg_2pdf

26_letter_from_fi_registered_versionpdf

30_bto_meeting_with_nbpt-2_registered_versionpdf

34_reply_to_finland_25-4-2014_registered_versionpdf

36_nbt_platform_multilateral_meeting_25_06_2014_steering_note_registered_versionpdf

42_e-mail_dow_agro_to_jrc_-_10-4-2012pdf

431_presentation_cnudde_31-5-2012pdf

44_bto_meeting_31-5-2012pdf

45_proposed_agenda_meeting_22-6-2012pdf

462_ppt_schouten_22-6-2012pdf

51_e-mail_nbt_platform_31-5-2013pdf

511_legal_briefing_paper_-_28-5-2013pdf

512_summary_legal_paper_22-5-2013pdf

513_nbt_factsheetspdf

53_e-mail_from_dow_agro_to_sanco_2-7-2013pdf

54_internal_e-mail_dg_sanco_8-7-2013pdf

561_esa_position_paper_-_fev_2014pdf

57_invitation_to_the_meeting_on_the_future_of_plant_nbts_in_the_eu_25_06_2014pdf

nbt_platform_multilateral_meeting_ares20144089348_-_signed_version_-_third_batchpdf

9pdf

6pdf

12pdf

18pdf

17_20150610_vib_letter_redactedpdf

18_20150615_lettre_autorites_competentes_redactedpdf

21_20150702_reply_to_nbtp-redactedpdf

24_20150709_reply_to_vib_redactedpdf

27_20150722_vib_redactedpdf

28_bto_-_meeting_l_miko_with_new_breeding_technique_platform_-_27_april_2015_redactedpdf

atd_2015-5344_-_doct_2pdf

atd_2015-5344_-_doct_7pdf

atd_2015-5344_-_doct_8pdf

ares20155217184annex-ms_non_paperpdf

httpwwwvibbenleducatieDocumentsVIB_dossier_20schimmelresistent

EASAC Statement on New Breeding Techniques July 2015 httpwwweasaceufileadminPDF_sreports_statementsEasac_14_NBTpdf

EASAC Planting the Future - opportunities and challenges for using crop genetic improvement technologies for sustainable agriculture June 2013

httpwwweasaceufileadminReportsPlanting_the_FutureEASAC_Planting

However one third of the working group are also member of PRRI an industry-minded lobby group of public scientists

Corporate Europe Observatory PRRI - Are these public researchers 2008 httpcorporateeuropeorgfood-and-agriculture200806prri-are-these-p

European Parliament Committee on Agriculture Hearing on ldquoNew Techniques for Plant Breedingrdquo 1 December 2015

httpspolcmssecureeuroparleuropaeucmsdatauploadd35d2641-ab77-49

Furthermore Schuttelaar amp Partners now lists only one client (Grodan a supplier to the horticulture sector) This is in sharp contrast to the lobby firmrsquos

own website where 11 clients from the food and biotech sectors are listed as examples of ldquocurrent and recent clientsrdquo

Schuttelaar amp Partners website As accessed 13 December 2015 httpwwwschuttelaar-partnerscomclients

EU Transparency Register website As accessed 15 November 2015 (No longer in public domain available from CEO)

EU Transparency Register Accessed 16 January 2016

Dorotheacutee Andreacutee DG SANTE Comment at EP Agriculture Committee hearing 1 December 2015

75

76

77

78

79

80

81

0

14_09-28_letter_de_redactedpdf

Tag Tag

genetically modified crops

GMOs

Belgian showfield of DutchGM DuRPhpotatoes

Related Latest

REPORT

Of apples and potatoesthe Dutch lobby for thederegulation ofcisgenesisFEBRUARY 2ND 2016 THE POWER OF

LOBBIES FOOD AND AGRICULTURE

The voice of the Dutch Government has been

loud and clear in Brussels on the issue of

cisgenic plants The Dutch have waged a

sustained campaign to have new GM

techniques ndash and in particular cisgenesis ndash

excluded from EU GMO regulations Several

Dutch ministries the Dutch Parliament the

Dutch Permanent Representation in Brussels

and Dutch MEPs have energetically pursued

this goal

STORY

Canadian company railroads EUdecision-making on new GM

FEBRUARY 2ND 2016 THE POWER OF LOBBIES FOOD AND

AGRICULTURE

At least one developer of new GM crops ndash

Canadian-based Cibus ndash has attempted to

bypass the European policy process by

presenting policy makers with a fait accompli

decisions by individual Member States on the

regulatory status of new techniques as well as

prematurely-launched trials of new GM crops

STORY

EU review of weedkillerglyphosate adds secrecyto controversy

JANUARY 14TH 2016 EFSA FOOD AND AGRICULTURE

More than 80 per cent of the national experts

involved in the EUs official assessment of

glyphosate refused to have their names

disclosed to the public

STORY

Solutions COP21Climate SmartAgriculture boostingthe technofix

DECEMBER 10TH 2015 CLIMATE AND ENERGY FOOD AND

AGRICULTURE

ldquoIf you like greenwashing clap your handsrdquo

1 of 321 of 32 next rsaquo

Corporate Europe Observatory

(CEO) is a research and campaign

group working to expose and

challenge the privileged access

and influence enjoyed by

corporations and their lobby

groups in EU policy making

Read more

CEO relies on grants and

donations to carry out our

research and campaign work By

making a donation or becoming a

friend of CEO you help to

support our efforts to expose

corporate lobbying increase

transparency and urge greater

democratic accountabililty in the

EU

Or

All written content on this

website is licensed under a

Creative Commons Attribution-

NonCommercial-ShareAlike 30

Unported License

Page 9: FOROEUROPA - Biotech lobby’s push for new GMOs to escape … · 2016-02-04 · With respect to cisgenesis and intragenesis, EFSA concluded that while intragenic plants would generate

necessary liaison efforts into motion and set up a meeting that took place in July 2015 The Platform also shifted focus to liaise

and gather information from EU member states and sought a meeting with the Commission (DGs SANTE AGRI and Trade) to

report back on these contacts

Furthermore at two occasions in 2015 GM developers got assistance from certain member states that have also been peddling a

pro-deregulation agenda with Brussels In May 2015 a lsquonon-paperrsquo authored by Germany the UK Ireland and Spain argued for the

deregulation of the ODM technique in particular using the same arguments as put forth by industry to argue that ldquoODM is a

variation of mutagenesisrdquo

In September the German food safety agency BVL in a joint exercise with its UK and Irish colleagues sent an interpretation of the

definition of a GMO in Directive 200118 to the Commission This document precisely echoes the industry discourse that a

product should only be regulated under EU GMO laws if it is produced by a GM process and if the result is a product that could

not have been achieved in a lsquonaturalrsquo way

Flemish biotechnology institute (VIB) and EASAC join the chorus

In this last phase corporate-backed research institutes like the Flemish VIB also stepped up their efforts in order to defend their

commercial interests On 5 June 2015 the VIB met with the Commission to discuss a number of new techniques Although the list

has not been disclosed following freedom of information requests according to the VIB ldquo the examples given represent concrete

business opportunities and vulnerable information from the viewpoint of competitionrdquo It appears likely from the Commission response

and a related email exchange on the topic that the VIB is eyeing cisgenesis and certain gene editing techniques VIB has an obvious

commercial interest in the deregulation of cisgenesis after having put its money on turning the failed Dutch cisgenic potato into a

Belgian specialty a blight-resistant Bintje a well known potato variety widely used for the countrys famous fries

Moreover in a remarkable statement addressed to the Commission in July 2015 the European Academies Science Advisory Council

(EASAC) also backed industrys views Their political demands dovetail with those of industry GMOs should be allowed to escape

regulation ldquowhen they do not contain foreign DNArdquo that GM products should be regulated only by trait and not technique and that the

use of the precautionary principle in GM regulation should be reconsidered The statement is based on the conclusions of an earlier

EASAC report Planting the Future This report was composed by a working group of experts acting in individual capacity nominated

by member academies of EASAC

Meanwhile in the European Parliament some MEPs unsuccessfully demanded a formal say in the process Others including Jan

Huitema (Liberals) and Anthea McIntyre (Conservatives) authored resolutions that included calls for the deregulation of new GM

techniques On 1 December 2015 a hearing took place in the European Parliament Agriculture Committee Edwin Hecker a NBT

Platform lobbyist and an employee of Schuttelaar amp Partners (although the latter was not disclosed) presented industrys views

again overstating the role of SMEs

Surprisingly only one week later the NBT Platform was deleted from Schuttelaar amp Partners list of clients in the register However

the information in the NBT Platforms entry and on its website remains unchanged (See box Does the NBT Platform still exist)

Does the NBT Platform still exist

Schuttelaar amp Partners made some remarkable changes to their registry entry on 7 December 2015 The NBT Platform has been deleted

as a client from the lobby groups entry This is contradictory as the NBT Platformrsquos entry is unchanged and still lists Mr Hecker as its

chair In line with this change the Commissions legal interpretation of Directive 200118 for the new GM techniques has been deleted

from the list of EU initiatives followed by the company

In addition the companys overall lobby-related expenses have been reduced tenfold from euro100000-500000 down to euro50000-99000

The consultancy now declares just a 08 FTE workload for lobbying activities This is at odds for instance with the fact that ten

employees currently hold lobby passes for the European Parliament

6 The Commissions interpretation Whose interests will prevail

All invested parties are now awaiting the Commissions decision to be presented in March 2016 Will the NBT Platform be

celebrating victory after achieving its Phase 4 Agreement goal Or will concerned governments NGOs and sustainable farming

67

68

69

70 71

72 73

74

75

76

77

78

79

80

organisations be relieved that the new GM technologies will be subject to the existing hard-won regulation

Maybe neither DG SANTE has already publicly stated that ldquosome will be pleased others disappointedrdquo indicating that at least

one perhaps more but not all of the new techniques will escape regulation as a result of the Commission decision If true this

would ndash no matter how many techniques are concerned ndash be a serious attack on food and environmental safety consumer choice

and transparency in the food chain as well as enhancing corporate concentration in the seed sector through patents

As Brussels itself realises the Commission release is probably just the beginning ndash and not the resolution ndash of this contentious

issue In all likelihood it will be the European Court of Justice that ultimately determines the regulatory fate of new GM

techniques The court case brought by environmental and farming organisations against Cibus ODM oilseed rape will therefore be

of great importance

In the meantime neither the biotech industry nor its financiers are likely to have the certainty they have been striving for

Furthermore other actors may still come into play Food distributors may demand direct liability for new GM products to those

who put them on the market And parliaments may insist on the labelling of new GM products like has happened in the

Netherlands The TTIP negotiations on the other hand may become a force against a proper regulation of GM 20 Environmental

and sustainable farming groups will have to remain on high alert

81

- Eckerstorfer M et al Environmental Agency Austria Technical report New plant breeding techniques and risks associated with their application 2014

httpwwwumweltbundesamtatfileadminsitepublikationenREP0477pd

- Kraumlmer L Legal questions concerning new methods for changing the genetic conditions in plants Legal analysis commissioned by Arbeitsgemeinschaft

baumluerliche Landwirtschaft (AbL) Bund fuumlr Umwelt und Naturschutz (BUND) etc September 2015

httpwwwtestbiotechorgsitesdefaultfilesKraemer_Legal20questions

- Spranger TM Legal Analysis of the applicability of Directive 200118EC on genome editing technologies Commissioned by the German Federal Agency

for Nature Conservation October 2015 httpbfndefileadminBfNagrogentechnikDokumenteLegal_analysis_of_g

Steinbrecher Ricarda Genetic Engineering in plants and the ldquoNew Breeding Techniques (NBTs)rdquo December 2015

httpwwweconexusinfopublicationgenetic-engineering-plants-and-new-

Corporate Europe Observatory and Inf OGM TTIP released emails show biotech seeds on the trade talks table 2 July 2015

httpcorporateeuropeorgfood-and-agriculture201507ttip-released-em

The Working Group was made up of two experts nominated from each member state Its final report was completed in 2012 but was never officially

published

See for a description of the techniques and reasons why they should be regulated Steinbrecher Ricarda Genetic Engineering in plants and the ldquoNew

Breeding Techniques (NBTs)rdquo December 2015 httpwwweconexusinfopublicationgenetic-engineering-plants-and-new-

Testbiotech Gene-editing and plants amp animals used in food production some technical socio-economic and legal aspects Backgrounder for Hearing on

ldquoNew Techniques for Plant Breedingrdquo in the EP Agriculture Committee 1 December 2015

httpwwwtestbiotechorgsitesdefaultfilesLegal20and20technical2

Waltz Emily Tiptoeing around Transgenics In Nature Biotechnology volume 30 number 3 March 2012

NBT Platform Fact sheet New Breeding Techniques Seizing the opportunity Version 2013

The Commission prioritised these techniques specifically since they entail ldquothe introduction of exogenous [that is lsquoforeignrsquo] genetic material into the

host which is the case for these techniques as it is for transgenesisrdquo

DG SANCO Steering note for NBT Platform meeting ldquoThe future of plant breeding techniques in the European Union 25 June 2014 Obtained through

Freedom of Information request by CEO

Several additional pieces of analysis were allocated to the Commissions Joint Research Centre (JRC)

EFSA Scientific opinion addressing the safety assessment of plants developed using cisgenesis and intragenesis 2012

httpwwwefsaeuropaeufrefsajournalpub2561

DG SANCO Background brief at the occasion of visit Mr Ladislav Miko to Keygene 26 January 2012 Obtained through Freedom of Information request

by CEO

DG SANCO Presentation on New Breeding Techniques at European Seed Association Annual Meeting 15 October 2012 Obtained through Freedom of

Information request by CEO

DG SANTE Email to NBT Platform 02 July 2015 Obtained through Freedom of Information request by CEO

European Parliament Follow up to the European Parliament resolution on ldquoPlant breeding what options to increase quality and yieldsrdquo (EP reference

number A7-00442014 P7_TA-PROV(2014)0131) 28 May 2014

BASF Letter to DEFRA 29 April 2013 Obtained through Freedom of Information request by GeneWatch

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

Finnish Board of Gene Technology Letter to Paolo Testori Coggi Director-General of DG SANCO 17 February 2014 Obtained through Freedom of

Information request by CEO

DG SANCO Letter to Finnish Board for Gene Technology 25 April 2014 Obtained through Freedom of Information request by CEO

NBT Platform two-pager April 2015 httpwwwnbtplatformorgbackground-documentsfactsheets2-pager-nbt-p

Bussink Michiel De strategie in Nederland Geen slapende honden wakker maken In Milieudefensie Magazine 1999-3

RTRS website Accessed 10 December 2015 httpwwwresponsiblesoyorgabout-rtrsgovernancetask-forcestask-for

Corporate Europe Observatory Roundtable on Responsible Soya - The certifying smokescreen 22 May 2012

httpcorporateeuropeorgsitesdefaultfilespublicationsrtrs_briefin

DG Trade Report from meeting with NBT Platform 07 June 2012 Obtained by Freedom of Information request by CEO

European Seed Association Position paper New Breeding Techniques ndash ensuring Progress and Diversity in Plant Breeding July 2012

httpswwweuroseedseusystemfilespublicationsfilesesa_1204462pdf

NBT Platform Fact sheet New Breeding Techniques Seizing the opportunity Version 2013

Cnudde F Dow Agrosciences Presentation Use of Zinc Finger Nucleases for plant breeding purposes May 2012 Obtained through Freedom of

Information request by CEO

Steinbrecher Ricarda Genetic Engineering in plants and the ldquoNew Breeding Techniques (NBTs)rdquo December 2015

httpwwweconexusinfopublicationgenetic-engineering-plants-and-new-

- httpswwwgrainorgesarticleentries588-gm-soybean-latin-america-s-

- httpslasojamatanetfilesparaguay-humanrights-reportpdf

Testbiotech Gene-editing and plants amp animals used in food production some technical socio-economic and legal aspects Backgrounder for Hearing on

ldquoNew Techniques for Plant Breedingrdquo in the EP Agriculture Committee 1 December 2015

httpwwwtestbiotechorgsitesdefaultfilesLegal20and20technical2

Fagan J Antoniou M Robinson C Earth Open Source GMO Myths and Truths 2014 httpgmomythsandtruthsearthopensourceorg

Greenpeace Twenty years of failure Why GM crops have failed to deliver on their promises November 2015

httpwwwgreenpeaceorginternationalGlobalinternationalpublication

NBT Platform two-pager April 2015 httpwwwnbtplatformorgbackground-documentsfactsheets2-pager-nbt-p

NBT Platform Email to DG Trade 18 May 2015 Obtained through Freedom of Information request by CEO Doc 2 A2D Trade

NBT Platform two-pager April 2015 httpwwwnbtplatformorgbackground-documentsfactsheets2-pager-nbt-p

EU Transparency Register Accessed 11 January 2016 httpeceuropaeutransparencyregisterpublicconsultationdisplaylobb

The lobbying activities covered by the register include all those that are ldquocarried out with the objective of directly or indirectly influencing the

formulation or implementation of policy and the decision-making processes of the EU institutions irrespective of where they are undertaken and of the

channel or medium of communication used for example via outsourcing media contracts with professional intermediaries think tanks platforms

forums campaigns and grassroots initiativesrdquo Article 7 httpeur-lexeuropaeulegal-contentENTXTHTMLuri=CELEX32014Q0919

Website NBT Platform Accessed 8 November 2015 Compared to a list provided in 2014 two members dropped off Cellectis Plant Sciences and Centre

RampD Nestleacute Tours httpwwwnbtplatformorg

DG SANCO Steering note for Mr Ladislav Miko at the occasion of a visit by Mr Hugo von Meijenfeldt Acting DG Environment Environment Ministry

Netherlands 15 November 2012

DG Trade Report from meeting with NBT Platform 07 June 2012 Obtained by Freedom of Information request by CEO

Inova Fruit is owned by five shareholders all large fruit auction companies 49 of shares are owned for instance by the Greenery that has over 1400

employees

For example Rothamsted Research website As accessed 11 January 2016 httpwwwrothamstedacuknewsnew-collaborative-research-project-gets

VIB website As accessed 21 December 2015 httpwwwvibbenlover-viborganisatiePaginasAlgemene-vergaderingaspx

ENERGYPOPLAR website As accessed 21 December 2015 httpwwwenergypoplareuinstitutionsphpid=40

NBT Platform two-pager April 2015 httpwwwnbtplatformorgbackground-documentsfactsheets2-pager-nbt-p

DG SANCO Notes of meeting with NBT Platform of 31 May 2012 06 June 2012 Obtained through Freedom of Information request by CEO

NBT Platform Proposed agenda for meeting on 22 June 2012 Obtained through Freedom of Information request by CEO

Schouten Henk Wageningen University and Research Center and Inova Fruit Presentation to European Commission Legal arguments to keep plants

from novel breeding techniques such as cisgenesis outside the GMO regulation 22 June 2012 Obtained through Freedom of Information request by CEO

Kempen F C Jung Genetic Modification of Plants Agriculture Horticulture and Forestry 2010 In Biotechnology in Agriculture and Forestry Springer

httpelibrarycomngUploadFilesfile0_10097pdf

Schuttelaar amp Partners was also hired for this project to draw up a communication plan ldquofor the acceptance and marketingrdquo of the cisgenic apple

National Academic Research and Collaborations Information System website As accessed 12 January 2016

httpwwwnarcisnlresearchRecordIDOND1310571

NBT Platform Email to DG SANCO 10 July 2012 Obtained through Freedom of Information request by CEO

17

18

19

20

21

22

23

24

25

26

27

28

29

30

31

32

33

34

35

36

37

38

39

40

41

42

43

44

45

46

47

48

49

DG Trade Report from meeting with NBT Platform 07 June 2012 Obtained through Freedom of Information request by CEO

DG Trade Report from meeting with Schuttelaar amp Partners on new breeding techniques 15 March 2012 Obtained through Freedom of Information

request by CEO

European Seed Association (ESA) Position paper Promoting and Enabling Innovation in Plant Breeding February 2014 Obtained through Freedom of

Information request by CEO

NBT Platform Legal Briefing Paper The regulatory status of plants resulting from New Breeding Technologies Version of 28 May 2013 Obtained

through Freedom of Information request by CEO

NBT Platform Summary of Legal Briefing Paper ldquoThe regulatory status of plants resulting fromNew Breeding Technologiesrdquo Obtained through Freedom

of Information request by CEO 22 May 2013 doc 512

The Directive 200118 (Annex 1B) lists two techniques ndash cell fusion and mutagenesis ndash for which an exemption has been granted and that are therefore

excluded from its scope As these two techniques predated the Directive by many years EU authorities assumed there was a lsquohistory of safe usersquo

The following documents exemplify the pro-deregulation arguments Each uses one or more of the points listed in the table

- European Technology Platform Plants for the Future Position paper New Breeding Techniques - Ensuring an Innovative and Diversified European

Agriculture September 2012 httpwwwepsoweborgfile1096

- European Seed Association Regulatory approaches to modern plant breeding - the case of mutagenesis and new gene editing technologies 20 July 2015

httpswwweuroseedseusystemfilespublicationsfilesesa_150543_0pdf

- CropLife International Position Paper Regulatory oversight of products developed through new breeding techniques 2014 httpscroplifeorgwp-

contentuploadspdf_filesRegulatory-Oversight-o

- NBT Platform Factsheet Oligonucleotide-Directed Mutagenesis accelerating innovation 2013 httpwwwnbtplatformorgbackground-

documentsfactsheetsfactsheet-oli

- NBT Platform Legal Briefing Paper The regulatory status of plants resulting from New Breeding Technologies Version of 28 May 2013

- Kraumlmer L Legal questions concerning new methods for changing the genetic conditions in plants Legal analysis commissioned by Arbeitsgemeinschaft

baumluerliche Landwirtschaft (AbL) Bund fuumlr Umwelt und Naturschutz (BUND) etc September 2015

httpwwwtestbiotechorgsitesdefaultfilesKraemer_Legal20questions

- Spranger TM Legal Analysis of the applicability of Directive 200118EC on genome editing technologies Commissioned by the German Federal Agency

for Nature Conservation October 2015 httpbfndefileadminBfNagrogentechnikDokumenteLegal_analysis_of_g

- Cotter J Zimmermann D Van Bekkem H Greenpeace Applications of the EU and Cartagena definitions of a GMO to the classification of plants

developed by cisgenesis and gene-editing techniques 2015 httpwwwgreenpeacetogreenpeacewp-contentuploads201511Applicati

- Reseau Semences Paysannes Confederation Paysanne et al Statut juridique des produits issus des nouvelles techniques de modification geacuteneacutetique des

plantes

DG SANCO Notes from meeting with NBT Platform 21 March 2014 Obtained through Freedom of Information request by CEO

NBT Platform and ETP Plants for the Future Meeting report Multilateral meeting lsquothe future of plant breeding techniques in the European Unionrsquo

Obtained through Freedom of Information request by CEO 25 June 2014

Ibid

Dow Agrosciences and DG SANCOJRC Emails April 2012 and July 2013 Obtained through Freedom of Information request by CEO

DG SANCO Internal email 8 July 2013 Obtained through Freedom of Information request by CEO

Corporate Europe Observatory and Inf OGM TTIP released emails show biotech seeds on the trade talks table 2 July 2015

httpcorporateeuropeorgfood-and-agriculture201507ttip-released-em

European Commission Letter to Competent Authorities 5 June 2015 Obtained through Freedom of Information request by CEO

Cibus Europe Letter to DG SANCO January 2015 Obtained through Freedom of Information request by CEO

Schuttelaar amp Partners Letter to Commissioner Vytenis Andriukaitis 1 December 2014 Obtained through Freedom of Information request by CEO

NBT Platform Email to Mr Ladislav Miko (DG SANTE) 26 February 2015 Obtained through Freedom of Information request by CEO

NBT Platform Email to DG Trade 18 May 2015 Obtained through Freedom of Information request by CEO

According to Agrafacts the non-paper was authored by German UK Irish and Spanish authorities

Non-paper on the regulatory status of plants generated by oligonucleotide-directed mutagenesis (ODM) 21 May 2015 Obtained through Freedom of

Information request by CEO

BVL Legal interpretation to DG SANTE 28 September 2015 Obtained through Freedom of Information request by CEO

DG SANTE Reply to Vlaams Instituut voor Biotechnologie (VIB) 9 July 2015 Obtained through Freedom of Information request by CEO (doc 24 a2d3)

Vlaams Instituut voor Biotechnologie (VIB) Letter to Mr Ladislav Miko (DG SANTE) 10 June 2015 Obtained through Freedom of Information request by

CEO

DG SANTE Reply to Vlaams Instituut voor Biotechnologie (VIB) 9 July 2015 Obtained through Freedom of Information request by CEO

Vlaams Instituut voor Biotechnologie (VIB) Email to DG SANTE 6 July 2015 Obtained through Freedom of Information request by CEO

VIB Fact series Een schimmelresistente aardappel voor Belgieuml December 2014

50

51

52

53

54

55

56

57

58

59

60

61

62

63

64

65

66

67

68

69

70

71

72

73

74

Food and agriculture

Attached files Attached files

1_briefing_visit_keygenepdf

6pdf

13_presentation_at_esa_-_15-10-2012pdf

14_briefing_visit_nl_dg_2pdf

26_letter_from_fi_registered_versionpdf

30_bto_meeting_with_nbpt-2_registered_versionpdf

34_reply_to_finland_25-4-2014_registered_versionpdf

36_nbt_platform_multilateral_meeting_25_06_2014_steering_note_registered_versionpdf

42_e-mail_dow_agro_to_jrc_-_10-4-2012pdf

431_presentation_cnudde_31-5-2012pdf

44_bto_meeting_31-5-2012pdf

45_proposed_agenda_meeting_22-6-2012pdf

462_ppt_schouten_22-6-2012pdf

51_e-mail_nbt_platform_31-5-2013pdf

511_legal_briefing_paper_-_28-5-2013pdf

512_summary_legal_paper_22-5-2013pdf

513_nbt_factsheetspdf

53_e-mail_from_dow_agro_to_sanco_2-7-2013pdf

54_internal_e-mail_dg_sanco_8-7-2013pdf

561_esa_position_paper_-_fev_2014pdf

57_invitation_to_the_meeting_on_the_future_of_plant_nbts_in_the_eu_25_06_2014pdf

nbt_platform_multilateral_meeting_ares20144089348_-_signed_version_-_third_batchpdf

9pdf

6pdf

12pdf

18pdf

17_20150610_vib_letter_redactedpdf

18_20150615_lettre_autorites_competentes_redactedpdf

21_20150702_reply_to_nbtp-redactedpdf

24_20150709_reply_to_vib_redactedpdf

27_20150722_vib_redactedpdf

28_bto_-_meeting_l_miko_with_new_breeding_technique_platform_-_27_april_2015_redactedpdf

atd_2015-5344_-_doct_2pdf

atd_2015-5344_-_doct_7pdf

atd_2015-5344_-_doct_8pdf

ares20155217184annex-ms_non_paperpdf

httpwwwvibbenleducatieDocumentsVIB_dossier_20schimmelresistent

EASAC Statement on New Breeding Techniques July 2015 httpwwweasaceufileadminPDF_sreports_statementsEasac_14_NBTpdf

EASAC Planting the Future - opportunities and challenges for using crop genetic improvement technologies for sustainable agriculture June 2013

httpwwweasaceufileadminReportsPlanting_the_FutureEASAC_Planting

However one third of the working group are also member of PRRI an industry-minded lobby group of public scientists

Corporate Europe Observatory PRRI - Are these public researchers 2008 httpcorporateeuropeorgfood-and-agriculture200806prri-are-these-p

European Parliament Committee on Agriculture Hearing on ldquoNew Techniques for Plant Breedingrdquo 1 December 2015

httpspolcmssecureeuroparleuropaeucmsdatauploadd35d2641-ab77-49

Furthermore Schuttelaar amp Partners now lists only one client (Grodan a supplier to the horticulture sector) This is in sharp contrast to the lobby firmrsquos

own website where 11 clients from the food and biotech sectors are listed as examples of ldquocurrent and recent clientsrdquo

Schuttelaar amp Partners website As accessed 13 December 2015 httpwwwschuttelaar-partnerscomclients

EU Transparency Register website As accessed 15 November 2015 (No longer in public domain available from CEO)

EU Transparency Register Accessed 16 January 2016

Dorotheacutee Andreacutee DG SANTE Comment at EP Agriculture Committee hearing 1 December 2015

75

76

77

78

79

80

81

0

14_09-28_letter_de_redactedpdf

Tag Tag

genetically modified crops

GMOs

Belgian showfield of DutchGM DuRPhpotatoes

Related Latest

REPORT

Of apples and potatoesthe Dutch lobby for thederegulation ofcisgenesisFEBRUARY 2ND 2016 THE POWER OF

LOBBIES FOOD AND AGRICULTURE

The voice of the Dutch Government has been

loud and clear in Brussels on the issue of

cisgenic plants The Dutch have waged a

sustained campaign to have new GM

techniques ndash and in particular cisgenesis ndash

excluded from EU GMO regulations Several

Dutch ministries the Dutch Parliament the

Dutch Permanent Representation in Brussels

and Dutch MEPs have energetically pursued

this goal

STORY

Canadian company railroads EUdecision-making on new GM

FEBRUARY 2ND 2016 THE POWER OF LOBBIES FOOD AND

AGRICULTURE

At least one developer of new GM crops ndash

Canadian-based Cibus ndash has attempted to

bypass the European policy process by

presenting policy makers with a fait accompli

decisions by individual Member States on the

regulatory status of new techniques as well as

prematurely-launched trials of new GM crops

STORY

EU review of weedkillerglyphosate adds secrecyto controversy

JANUARY 14TH 2016 EFSA FOOD AND AGRICULTURE

More than 80 per cent of the national experts

involved in the EUs official assessment of

glyphosate refused to have their names

disclosed to the public

STORY

Solutions COP21Climate SmartAgriculture boostingthe technofix

DECEMBER 10TH 2015 CLIMATE AND ENERGY FOOD AND

AGRICULTURE

ldquoIf you like greenwashing clap your handsrdquo

1 of 321 of 32 next rsaquo

Corporate Europe Observatory

(CEO) is a research and campaign

group working to expose and

challenge the privileged access

and influence enjoyed by

corporations and their lobby

groups in EU policy making

Read more

CEO relies on grants and

donations to carry out our

research and campaign work By

making a donation or becoming a

friend of CEO you help to

support our efforts to expose

corporate lobbying increase

transparency and urge greater

democratic accountabililty in the

EU

Or

All written content on this

website is licensed under a

Creative Commons Attribution-

NonCommercial-ShareAlike 30

Unported License

Page 10: FOROEUROPA - Biotech lobby’s push for new GMOs to escape … · 2016-02-04 · With respect to cisgenesis and intragenesis, EFSA concluded that while intragenic plants would generate

organisations be relieved that the new GM technologies will be subject to the existing hard-won regulation

Maybe neither DG SANTE has already publicly stated that ldquosome will be pleased others disappointedrdquo indicating that at least

one perhaps more but not all of the new techniques will escape regulation as a result of the Commission decision If true this

would ndash no matter how many techniques are concerned ndash be a serious attack on food and environmental safety consumer choice

and transparency in the food chain as well as enhancing corporate concentration in the seed sector through patents

As Brussels itself realises the Commission release is probably just the beginning ndash and not the resolution ndash of this contentious

issue In all likelihood it will be the European Court of Justice that ultimately determines the regulatory fate of new GM

techniques The court case brought by environmental and farming organisations against Cibus ODM oilseed rape will therefore be

of great importance

In the meantime neither the biotech industry nor its financiers are likely to have the certainty they have been striving for

Furthermore other actors may still come into play Food distributors may demand direct liability for new GM products to those

who put them on the market And parliaments may insist on the labelling of new GM products like has happened in the

Netherlands The TTIP negotiations on the other hand may become a force against a proper regulation of GM 20 Environmental

and sustainable farming groups will have to remain on high alert

81

- Eckerstorfer M et al Environmental Agency Austria Technical report New plant breeding techniques and risks associated with their application 2014

httpwwwumweltbundesamtatfileadminsitepublikationenREP0477pd

- Kraumlmer L Legal questions concerning new methods for changing the genetic conditions in plants Legal analysis commissioned by Arbeitsgemeinschaft

baumluerliche Landwirtschaft (AbL) Bund fuumlr Umwelt und Naturschutz (BUND) etc September 2015

httpwwwtestbiotechorgsitesdefaultfilesKraemer_Legal20questions

- Spranger TM Legal Analysis of the applicability of Directive 200118EC on genome editing technologies Commissioned by the German Federal Agency

for Nature Conservation October 2015 httpbfndefileadminBfNagrogentechnikDokumenteLegal_analysis_of_g

Steinbrecher Ricarda Genetic Engineering in plants and the ldquoNew Breeding Techniques (NBTs)rdquo December 2015

httpwwweconexusinfopublicationgenetic-engineering-plants-and-new-

Corporate Europe Observatory and Inf OGM TTIP released emails show biotech seeds on the trade talks table 2 July 2015

httpcorporateeuropeorgfood-and-agriculture201507ttip-released-em

The Working Group was made up of two experts nominated from each member state Its final report was completed in 2012 but was never officially

published

See for a description of the techniques and reasons why they should be regulated Steinbrecher Ricarda Genetic Engineering in plants and the ldquoNew

Breeding Techniques (NBTs)rdquo December 2015 httpwwweconexusinfopublicationgenetic-engineering-plants-and-new-

Testbiotech Gene-editing and plants amp animals used in food production some technical socio-economic and legal aspects Backgrounder for Hearing on

ldquoNew Techniques for Plant Breedingrdquo in the EP Agriculture Committee 1 December 2015

httpwwwtestbiotechorgsitesdefaultfilesLegal20and20technical2

Waltz Emily Tiptoeing around Transgenics In Nature Biotechnology volume 30 number 3 March 2012

NBT Platform Fact sheet New Breeding Techniques Seizing the opportunity Version 2013

The Commission prioritised these techniques specifically since they entail ldquothe introduction of exogenous [that is lsquoforeignrsquo] genetic material into the

host which is the case for these techniques as it is for transgenesisrdquo

DG SANCO Steering note for NBT Platform meeting ldquoThe future of plant breeding techniques in the European Union 25 June 2014 Obtained through

Freedom of Information request by CEO

Several additional pieces of analysis were allocated to the Commissions Joint Research Centre (JRC)

EFSA Scientific opinion addressing the safety assessment of plants developed using cisgenesis and intragenesis 2012

httpwwwefsaeuropaeufrefsajournalpub2561

DG SANCO Background brief at the occasion of visit Mr Ladislav Miko to Keygene 26 January 2012 Obtained through Freedom of Information request

by CEO

DG SANCO Presentation on New Breeding Techniques at European Seed Association Annual Meeting 15 October 2012 Obtained through Freedom of

Information request by CEO

DG SANTE Email to NBT Platform 02 July 2015 Obtained through Freedom of Information request by CEO

European Parliament Follow up to the European Parliament resolution on ldquoPlant breeding what options to increase quality and yieldsrdquo (EP reference

number A7-00442014 P7_TA-PROV(2014)0131) 28 May 2014

BASF Letter to DEFRA 29 April 2013 Obtained through Freedom of Information request by GeneWatch

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

Finnish Board of Gene Technology Letter to Paolo Testori Coggi Director-General of DG SANCO 17 February 2014 Obtained through Freedom of

Information request by CEO

DG SANCO Letter to Finnish Board for Gene Technology 25 April 2014 Obtained through Freedom of Information request by CEO

NBT Platform two-pager April 2015 httpwwwnbtplatformorgbackground-documentsfactsheets2-pager-nbt-p

Bussink Michiel De strategie in Nederland Geen slapende honden wakker maken In Milieudefensie Magazine 1999-3

RTRS website Accessed 10 December 2015 httpwwwresponsiblesoyorgabout-rtrsgovernancetask-forcestask-for

Corporate Europe Observatory Roundtable on Responsible Soya - The certifying smokescreen 22 May 2012

httpcorporateeuropeorgsitesdefaultfilespublicationsrtrs_briefin

DG Trade Report from meeting with NBT Platform 07 June 2012 Obtained by Freedom of Information request by CEO

European Seed Association Position paper New Breeding Techniques ndash ensuring Progress and Diversity in Plant Breeding July 2012

httpswwweuroseedseusystemfilespublicationsfilesesa_1204462pdf

NBT Platform Fact sheet New Breeding Techniques Seizing the opportunity Version 2013

Cnudde F Dow Agrosciences Presentation Use of Zinc Finger Nucleases for plant breeding purposes May 2012 Obtained through Freedom of

Information request by CEO

Steinbrecher Ricarda Genetic Engineering in plants and the ldquoNew Breeding Techniques (NBTs)rdquo December 2015

httpwwweconexusinfopublicationgenetic-engineering-plants-and-new-

- httpswwwgrainorgesarticleentries588-gm-soybean-latin-america-s-

- httpslasojamatanetfilesparaguay-humanrights-reportpdf

Testbiotech Gene-editing and plants amp animals used in food production some technical socio-economic and legal aspects Backgrounder for Hearing on

ldquoNew Techniques for Plant Breedingrdquo in the EP Agriculture Committee 1 December 2015

httpwwwtestbiotechorgsitesdefaultfilesLegal20and20technical2

Fagan J Antoniou M Robinson C Earth Open Source GMO Myths and Truths 2014 httpgmomythsandtruthsearthopensourceorg

Greenpeace Twenty years of failure Why GM crops have failed to deliver on their promises November 2015

httpwwwgreenpeaceorginternationalGlobalinternationalpublication

NBT Platform two-pager April 2015 httpwwwnbtplatformorgbackground-documentsfactsheets2-pager-nbt-p

NBT Platform Email to DG Trade 18 May 2015 Obtained through Freedom of Information request by CEO Doc 2 A2D Trade

NBT Platform two-pager April 2015 httpwwwnbtplatformorgbackground-documentsfactsheets2-pager-nbt-p

EU Transparency Register Accessed 11 January 2016 httpeceuropaeutransparencyregisterpublicconsultationdisplaylobb

The lobbying activities covered by the register include all those that are ldquocarried out with the objective of directly or indirectly influencing the

formulation or implementation of policy and the decision-making processes of the EU institutions irrespective of where they are undertaken and of the

channel or medium of communication used for example via outsourcing media contracts with professional intermediaries think tanks platforms

forums campaigns and grassroots initiativesrdquo Article 7 httpeur-lexeuropaeulegal-contentENTXTHTMLuri=CELEX32014Q0919

Website NBT Platform Accessed 8 November 2015 Compared to a list provided in 2014 two members dropped off Cellectis Plant Sciences and Centre

RampD Nestleacute Tours httpwwwnbtplatformorg

DG SANCO Steering note for Mr Ladislav Miko at the occasion of a visit by Mr Hugo von Meijenfeldt Acting DG Environment Environment Ministry

Netherlands 15 November 2012

DG Trade Report from meeting with NBT Platform 07 June 2012 Obtained by Freedom of Information request by CEO

Inova Fruit is owned by five shareholders all large fruit auction companies 49 of shares are owned for instance by the Greenery that has over 1400

employees

For example Rothamsted Research website As accessed 11 January 2016 httpwwwrothamstedacuknewsnew-collaborative-research-project-gets

VIB website As accessed 21 December 2015 httpwwwvibbenlover-viborganisatiePaginasAlgemene-vergaderingaspx

ENERGYPOPLAR website As accessed 21 December 2015 httpwwwenergypoplareuinstitutionsphpid=40

NBT Platform two-pager April 2015 httpwwwnbtplatformorgbackground-documentsfactsheets2-pager-nbt-p

DG SANCO Notes of meeting with NBT Platform of 31 May 2012 06 June 2012 Obtained through Freedom of Information request by CEO

NBT Platform Proposed agenda for meeting on 22 June 2012 Obtained through Freedom of Information request by CEO

Schouten Henk Wageningen University and Research Center and Inova Fruit Presentation to European Commission Legal arguments to keep plants

from novel breeding techniques such as cisgenesis outside the GMO regulation 22 June 2012 Obtained through Freedom of Information request by CEO

Kempen F C Jung Genetic Modification of Plants Agriculture Horticulture and Forestry 2010 In Biotechnology in Agriculture and Forestry Springer

httpelibrarycomngUploadFilesfile0_10097pdf

Schuttelaar amp Partners was also hired for this project to draw up a communication plan ldquofor the acceptance and marketingrdquo of the cisgenic apple

National Academic Research and Collaborations Information System website As accessed 12 January 2016

httpwwwnarcisnlresearchRecordIDOND1310571

NBT Platform Email to DG SANCO 10 July 2012 Obtained through Freedom of Information request by CEO

17

18

19

20

21

22

23

24

25

26

27

28

29

30

31

32

33

34

35

36

37

38

39

40

41

42

43

44

45

46

47

48

49

DG Trade Report from meeting with NBT Platform 07 June 2012 Obtained through Freedom of Information request by CEO

DG Trade Report from meeting with Schuttelaar amp Partners on new breeding techniques 15 March 2012 Obtained through Freedom of Information

request by CEO

European Seed Association (ESA) Position paper Promoting and Enabling Innovation in Plant Breeding February 2014 Obtained through Freedom of

Information request by CEO

NBT Platform Legal Briefing Paper The regulatory status of plants resulting from New Breeding Technologies Version of 28 May 2013 Obtained

through Freedom of Information request by CEO

NBT Platform Summary of Legal Briefing Paper ldquoThe regulatory status of plants resulting fromNew Breeding Technologiesrdquo Obtained through Freedom

of Information request by CEO 22 May 2013 doc 512

The Directive 200118 (Annex 1B) lists two techniques ndash cell fusion and mutagenesis ndash for which an exemption has been granted and that are therefore

excluded from its scope As these two techniques predated the Directive by many years EU authorities assumed there was a lsquohistory of safe usersquo

The following documents exemplify the pro-deregulation arguments Each uses one or more of the points listed in the table

- European Technology Platform Plants for the Future Position paper New Breeding Techniques - Ensuring an Innovative and Diversified European

Agriculture September 2012 httpwwwepsoweborgfile1096

- European Seed Association Regulatory approaches to modern plant breeding - the case of mutagenesis and new gene editing technologies 20 July 2015

httpswwweuroseedseusystemfilespublicationsfilesesa_150543_0pdf

- CropLife International Position Paper Regulatory oversight of products developed through new breeding techniques 2014 httpscroplifeorgwp-

contentuploadspdf_filesRegulatory-Oversight-o

- NBT Platform Factsheet Oligonucleotide-Directed Mutagenesis accelerating innovation 2013 httpwwwnbtplatformorgbackground-

documentsfactsheetsfactsheet-oli

- NBT Platform Legal Briefing Paper The regulatory status of plants resulting from New Breeding Technologies Version of 28 May 2013

- Kraumlmer L Legal questions concerning new methods for changing the genetic conditions in plants Legal analysis commissioned by Arbeitsgemeinschaft

baumluerliche Landwirtschaft (AbL) Bund fuumlr Umwelt und Naturschutz (BUND) etc September 2015

httpwwwtestbiotechorgsitesdefaultfilesKraemer_Legal20questions

- Spranger TM Legal Analysis of the applicability of Directive 200118EC on genome editing technologies Commissioned by the German Federal Agency

for Nature Conservation October 2015 httpbfndefileadminBfNagrogentechnikDokumenteLegal_analysis_of_g

- Cotter J Zimmermann D Van Bekkem H Greenpeace Applications of the EU and Cartagena definitions of a GMO to the classification of plants

developed by cisgenesis and gene-editing techniques 2015 httpwwwgreenpeacetogreenpeacewp-contentuploads201511Applicati

- Reseau Semences Paysannes Confederation Paysanne et al Statut juridique des produits issus des nouvelles techniques de modification geacuteneacutetique des

plantes

DG SANCO Notes from meeting with NBT Platform 21 March 2014 Obtained through Freedom of Information request by CEO

NBT Platform and ETP Plants for the Future Meeting report Multilateral meeting lsquothe future of plant breeding techniques in the European Unionrsquo

Obtained through Freedom of Information request by CEO 25 June 2014

Ibid

Dow Agrosciences and DG SANCOJRC Emails April 2012 and July 2013 Obtained through Freedom of Information request by CEO

DG SANCO Internal email 8 July 2013 Obtained through Freedom of Information request by CEO

Corporate Europe Observatory and Inf OGM TTIP released emails show biotech seeds on the trade talks table 2 July 2015

httpcorporateeuropeorgfood-and-agriculture201507ttip-released-em

European Commission Letter to Competent Authorities 5 June 2015 Obtained through Freedom of Information request by CEO

Cibus Europe Letter to DG SANCO January 2015 Obtained through Freedom of Information request by CEO

Schuttelaar amp Partners Letter to Commissioner Vytenis Andriukaitis 1 December 2014 Obtained through Freedom of Information request by CEO

NBT Platform Email to Mr Ladislav Miko (DG SANTE) 26 February 2015 Obtained through Freedom of Information request by CEO

NBT Platform Email to DG Trade 18 May 2015 Obtained through Freedom of Information request by CEO

According to Agrafacts the non-paper was authored by German UK Irish and Spanish authorities

Non-paper on the regulatory status of plants generated by oligonucleotide-directed mutagenesis (ODM) 21 May 2015 Obtained through Freedom of

Information request by CEO

BVL Legal interpretation to DG SANTE 28 September 2015 Obtained through Freedom of Information request by CEO

DG SANTE Reply to Vlaams Instituut voor Biotechnologie (VIB) 9 July 2015 Obtained through Freedom of Information request by CEO (doc 24 a2d3)

Vlaams Instituut voor Biotechnologie (VIB) Letter to Mr Ladislav Miko (DG SANTE) 10 June 2015 Obtained through Freedom of Information request by

CEO

DG SANTE Reply to Vlaams Instituut voor Biotechnologie (VIB) 9 July 2015 Obtained through Freedom of Information request by CEO

Vlaams Instituut voor Biotechnologie (VIB) Email to DG SANTE 6 July 2015 Obtained through Freedom of Information request by CEO

VIB Fact series Een schimmelresistente aardappel voor Belgieuml December 2014

50

51

52

53

54

55

56

57

58

59

60

61

62

63

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65

66

67

68

69

70

71

72

73

74

Food and agriculture

Attached files Attached files

1_briefing_visit_keygenepdf

6pdf

13_presentation_at_esa_-_15-10-2012pdf

14_briefing_visit_nl_dg_2pdf

26_letter_from_fi_registered_versionpdf

30_bto_meeting_with_nbpt-2_registered_versionpdf

34_reply_to_finland_25-4-2014_registered_versionpdf

36_nbt_platform_multilateral_meeting_25_06_2014_steering_note_registered_versionpdf

42_e-mail_dow_agro_to_jrc_-_10-4-2012pdf

431_presentation_cnudde_31-5-2012pdf

44_bto_meeting_31-5-2012pdf

45_proposed_agenda_meeting_22-6-2012pdf

462_ppt_schouten_22-6-2012pdf

51_e-mail_nbt_platform_31-5-2013pdf

511_legal_briefing_paper_-_28-5-2013pdf

512_summary_legal_paper_22-5-2013pdf

513_nbt_factsheetspdf

53_e-mail_from_dow_agro_to_sanco_2-7-2013pdf

54_internal_e-mail_dg_sanco_8-7-2013pdf

561_esa_position_paper_-_fev_2014pdf

57_invitation_to_the_meeting_on_the_future_of_plant_nbts_in_the_eu_25_06_2014pdf

nbt_platform_multilateral_meeting_ares20144089348_-_signed_version_-_third_batchpdf

9pdf

6pdf

12pdf

18pdf

17_20150610_vib_letter_redactedpdf

18_20150615_lettre_autorites_competentes_redactedpdf

21_20150702_reply_to_nbtp-redactedpdf

24_20150709_reply_to_vib_redactedpdf

27_20150722_vib_redactedpdf

28_bto_-_meeting_l_miko_with_new_breeding_technique_platform_-_27_april_2015_redactedpdf

atd_2015-5344_-_doct_2pdf

atd_2015-5344_-_doct_7pdf

atd_2015-5344_-_doct_8pdf

ares20155217184annex-ms_non_paperpdf

httpwwwvibbenleducatieDocumentsVIB_dossier_20schimmelresistent

EASAC Statement on New Breeding Techniques July 2015 httpwwweasaceufileadminPDF_sreports_statementsEasac_14_NBTpdf

EASAC Planting the Future - opportunities and challenges for using crop genetic improvement technologies for sustainable agriculture June 2013

httpwwweasaceufileadminReportsPlanting_the_FutureEASAC_Planting

However one third of the working group are also member of PRRI an industry-minded lobby group of public scientists

Corporate Europe Observatory PRRI - Are these public researchers 2008 httpcorporateeuropeorgfood-and-agriculture200806prri-are-these-p

European Parliament Committee on Agriculture Hearing on ldquoNew Techniques for Plant Breedingrdquo 1 December 2015

httpspolcmssecureeuroparleuropaeucmsdatauploadd35d2641-ab77-49

Furthermore Schuttelaar amp Partners now lists only one client (Grodan a supplier to the horticulture sector) This is in sharp contrast to the lobby firmrsquos

own website where 11 clients from the food and biotech sectors are listed as examples of ldquocurrent and recent clientsrdquo

Schuttelaar amp Partners website As accessed 13 December 2015 httpwwwschuttelaar-partnerscomclients

EU Transparency Register website As accessed 15 November 2015 (No longer in public domain available from CEO)

EU Transparency Register Accessed 16 January 2016

Dorotheacutee Andreacutee DG SANTE Comment at EP Agriculture Committee hearing 1 December 2015

75

76

77

78

79

80

81

0

14_09-28_letter_de_redactedpdf

Tag Tag

genetically modified crops

GMOs

Belgian showfield of DutchGM DuRPhpotatoes

Related Latest

REPORT

Of apples and potatoesthe Dutch lobby for thederegulation ofcisgenesisFEBRUARY 2ND 2016 THE POWER OF

LOBBIES FOOD AND AGRICULTURE

The voice of the Dutch Government has been

loud and clear in Brussels on the issue of

cisgenic plants The Dutch have waged a

sustained campaign to have new GM

techniques ndash and in particular cisgenesis ndash

excluded from EU GMO regulations Several

Dutch ministries the Dutch Parliament the

Dutch Permanent Representation in Brussels

and Dutch MEPs have energetically pursued

this goal

STORY

Canadian company railroads EUdecision-making on new GM

FEBRUARY 2ND 2016 THE POWER OF LOBBIES FOOD AND

AGRICULTURE

At least one developer of new GM crops ndash

Canadian-based Cibus ndash has attempted to

bypass the European policy process by

presenting policy makers with a fait accompli

decisions by individual Member States on the

regulatory status of new techniques as well as

prematurely-launched trials of new GM crops

STORY

EU review of weedkillerglyphosate adds secrecyto controversy

JANUARY 14TH 2016 EFSA FOOD AND AGRICULTURE

More than 80 per cent of the national experts

involved in the EUs official assessment of

glyphosate refused to have their names

disclosed to the public

STORY

Solutions COP21Climate SmartAgriculture boostingthe technofix

DECEMBER 10TH 2015 CLIMATE AND ENERGY FOOD AND

AGRICULTURE

ldquoIf you like greenwashing clap your handsrdquo

1 of 321 of 32 next rsaquo

Corporate Europe Observatory

(CEO) is a research and campaign

group working to expose and

challenge the privileged access

and influence enjoyed by

corporations and their lobby

groups in EU policy making

Read more

CEO relies on grants and

donations to carry out our

research and campaign work By

making a donation or becoming a

friend of CEO you help to

support our efforts to expose

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Or

All written content on this

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NonCommercial-ShareAlike 30

Unported License

Page 11: FOROEUROPA - Biotech lobby’s push for new GMOs to escape … · 2016-02-04 · With respect to cisgenesis and intragenesis, EFSA concluded that while intragenic plants would generate

Finnish Board of Gene Technology Letter to Paolo Testori Coggi Director-General of DG SANCO 17 February 2014 Obtained through Freedom of

Information request by CEO

DG SANCO Letter to Finnish Board for Gene Technology 25 April 2014 Obtained through Freedom of Information request by CEO

NBT Platform two-pager April 2015 httpwwwnbtplatformorgbackground-documentsfactsheets2-pager-nbt-p

Bussink Michiel De strategie in Nederland Geen slapende honden wakker maken In Milieudefensie Magazine 1999-3

RTRS website Accessed 10 December 2015 httpwwwresponsiblesoyorgabout-rtrsgovernancetask-forcestask-for

Corporate Europe Observatory Roundtable on Responsible Soya - The certifying smokescreen 22 May 2012

httpcorporateeuropeorgsitesdefaultfilespublicationsrtrs_briefin

DG Trade Report from meeting with NBT Platform 07 June 2012 Obtained by Freedom of Information request by CEO

European Seed Association Position paper New Breeding Techniques ndash ensuring Progress and Diversity in Plant Breeding July 2012

httpswwweuroseedseusystemfilespublicationsfilesesa_1204462pdf

NBT Platform Fact sheet New Breeding Techniques Seizing the opportunity Version 2013

Cnudde F Dow Agrosciences Presentation Use of Zinc Finger Nucleases for plant breeding purposes May 2012 Obtained through Freedom of

Information request by CEO

Steinbrecher Ricarda Genetic Engineering in plants and the ldquoNew Breeding Techniques (NBTs)rdquo December 2015

httpwwweconexusinfopublicationgenetic-engineering-plants-and-new-

- httpswwwgrainorgesarticleentries588-gm-soybean-latin-america-s-

- httpslasojamatanetfilesparaguay-humanrights-reportpdf

Testbiotech Gene-editing and plants amp animals used in food production some technical socio-economic and legal aspects Backgrounder for Hearing on

ldquoNew Techniques for Plant Breedingrdquo in the EP Agriculture Committee 1 December 2015

httpwwwtestbiotechorgsitesdefaultfilesLegal20and20technical2

Fagan J Antoniou M Robinson C Earth Open Source GMO Myths and Truths 2014 httpgmomythsandtruthsearthopensourceorg

Greenpeace Twenty years of failure Why GM crops have failed to deliver on their promises November 2015

httpwwwgreenpeaceorginternationalGlobalinternationalpublication

NBT Platform two-pager April 2015 httpwwwnbtplatformorgbackground-documentsfactsheets2-pager-nbt-p

NBT Platform Email to DG Trade 18 May 2015 Obtained through Freedom of Information request by CEO Doc 2 A2D Trade

NBT Platform two-pager April 2015 httpwwwnbtplatformorgbackground-documentsfactsheets2-pager-nbt-p

EU Transparency Register Accessed 11 January 2016 httpeceuropaeutransparencyregisterpublicconsultationdisplaylobb

The lobbying activities covered by the register include all those that are ldquocarried out with the objective of directly or indirectly influencing the

formulation or implementation of policy and the decision-making processes of the EU institutions irrespective of where they are undertaken and of the

channel or medium of communication used for example via outsourcing media contracts with professional intermediaries think tanks platforms

forums campaigns and grassroots initiativesrdquo Article 7 httpeur-lexeuropaeulegal-contentENTXTHTMLuri=CELEX32014Q0919

Website NBT Platform Accessed 8 November 2015 Compared to a list provided in 2014 two members dropped off Cellectis Plant Sciences and Centre

RampD Nestleacute Tours httpwwwnbtplatformorg

DG SANCO Steering note for Mr Ladislav Miko at the occasion of a visit by Mr Hugo von Meijenfeldt Acting DG Environment Environment Ministry

Netherlands 15 November 2012

DG Trade Report from meeting with NBT Platform 07 June 2012 Obtained by Freedom of Information request by CEO

Inova Fruit is owned by five shareholders all large fruit auction companies 49 of shares are owned for instance by the Greenery that has over 1400

employees

For example Rothamsted Research website As accessed 11 January 2016 httpwwwrothamstedacuknewsnew-collaborative-research-project-gets

VIB website As accessed 21 December 2015 httpwwwvibbenlover-viborganisatiePaginasAlgemene-vergaderingaspx

ENERGYPOPLAR website As accessed 21 December 2015 httpwwwenergypoplareuinstitutionsphpid=40

NBT Platform two-pager April 2015 httpwwwnbtplatformorgbackground-documentsfactsheets2-pager-nbt-p

DG SANCO Notes of meeting with NBT Platform of 31 May 2012 06 June 2012 Obtained through Freedom of Information request by CEO

NBT Platform Proposed agenda for meeting on 22 June 2012 Obtained through Freedom of Information request by CEO

Schouten Henk Wageningen University and Research Center and Inova Fruit Presentation to European Commission Legal arguments to keep plants

from novel breeding techniques such as cisgenesis outside the GMO regulation 22 June 2012 Obtained through Freedom of Information request by CEO

Kempen F C Jung Genetic Modification of Plants Agriculture Horticulture and Forestry 2010 In Biotechnology in Agriculture and Forestry Springer

httpelibrarycomngUploadFilesfile0_10097pdf

Schuttelaar amp Partners was also hired for this project to draw up a communication plan ldquofor the acceptance and marketingrdquo of the cisgenic apple

National Academic Research and Collaborations Information System website As accessed 12 January 2016

httpwwwnarcisnlresearchRecordIDOND1310571

NBT Platform Email to DG SANCO 10 July 2012 Obtained through Freedom of Information request by CEO

17

18

19

20

21

22

23

24

25

26

27

28

29

30

31

32

33

34

35

36

37

38

39

40

41

42

43

44

45

46

47

48

49

DG Trade Report from meeting with NBT Platform 07 June 2012 Obtained through Freedom of Information request by CEO

DG Trade Report from meeting with Schuttelaar amp Partners on new breeding techniques 15 March 2012 Obtained through Freedom of Information

request by CEO

European Seed Association (ESA) Position paper Promoting and Enabling Innovation in Plant Breeding February 2014 Obtained through Freedom of

Information request by CEO

NBT Platform Legal Briefing Paper The regulatory status of plants resulting from New Breeding Technologies Version of 28 May 2013 Obtained

through Freedom of Information request by CEO

NBT Platform Summary of Legal Briefing Paper ldquoThe regulatory status of plants resulting fromNew Breeding Technologiesrdquo Obtained through Freedom

of Information request by CEO 22 May 2013 doc 512

The Directive 200118 (Annex 1B) lists two techniques ndash cell fusion and mutagenesis ndash for which an exemption has been granted and that are therefore

excluded from its scope As these two techniques predated the Directive by many years EU authorities assumed there was a lsquohistory of safe usersquo

The following documents exemplify the pro-deregulation arguments Each uses one or more of the points listed in the table

- European Technology Platform Plants for the Future Position paper New Breeding Techniques - Ensuring an Innovative and Diversified European

Agriculture September 2012 httpwwwepsoweborgfile1096

- European Seed Association Regulatory approaches to modern plant breeding - the case of mutagenesis and new gene editing technologies 20 July 2015

httpswwweuroseedseusystemfilespublicationsfilesesa_150543_0pdf

- CropLife International Position Paper Regulatory oversight of products developed through new breeding techniques 2014 httpscroplifeorgwp-

contentuploadspdf_filesRegulatory-Oversight-o

- NBT Platform Factsheet Oligonucleotide-Directed Mutagenesis accelerating innovation 2013 httpwwwnbtplatformorgbackground-

documentsfactsheetsfactsheet-oli

- NBT Platform Legal Briefing Paper The regulatory status of plants resulting from New Breeding Technologies Version of 28 May 2013

- Kraumlmer L Legal questions concerning new methods for changing the genetic conditions in plants Legal analysis commissioned by Arbeitsgemeinschaft

baumluerliche Landwirtschaft (AbL) Bund fuumlr Umwelt und Naturschutz (BUND) etc September 2015

httpwwwtestbiotechorgsitesdefaultfilesKraemer_Legal20questions

- Spranger TM Legal Analysis of the applicability of Directive 200118EC on genome editing technologies Commissioned by the German Federal Agency

for Nature Conservation October 2015 httpbfndefileadminBfNagrogentechnikDokumenteLegal_analysis_of_g

- Cotter J Zimmermann D Van Bekkem H Greenpeace Applications of the EU and Cartagena definitions of a GMO to the classification of plants

developed by cisgenesis and gene-editing techniques 2015 httpwwwgreenpeacetogreenpeacewp-contentuploads201511Applicati

- Reseau Semences Paysannes Confederation Paysanne et al Statut juridique des produits issus des nouvelles techniques de modification geacuteneacutetique des

plantes

DG SANCO Notes from meeting with NBT Platform 21 March 2014 Obtained through Freedom of Information request by CEO

NBT Platform and ETP Plants for the Future Meeting report Multilateral meeting lsquothe future of plant breeding techniques in the European Unionrsquo

Obtained through Freedom of Information request by CEO 25 June 2014

Ibid

Dow Agrosciences and DG SANCOJRC Emails April 2012 and July 2013 Obtained through Freedom of Information request by CEO

DG SANCO Internal email 8 July 2013 Obtained through Freedom of Information request by CEO

Corporate Europe Observatory and Inf OGM TTIP released emails show biotech seeds on the trade talks table 2 July 2015

httpcorporateeuropeorgfood-and-agriculture201507ttip-released-em

European Commission Letter to Competent Authorities 5 June 2015 Obtained through Freedom of Information request by CEO

Cibus Europe Letter to DG SANCO January 2015 Obtained through Freedom of Information request by CEO

Schuttelaar amp Partners Letter to Commissioner Vytenis Andriukaitis 1 December 2014 Obtained through Freedom of Information request by CEO

NBT Platform Email to Mr Ladislav Miko (DG SANTE) 26 February 2015 Obtained through Freedom of Information request by CEO

NBT Platform Email to DG Trade 18 May 2015 Obtained through Freedom of Information request by CEO

According to Agrafacts the non-paper was authored by German UK Irish and Spanish authorities

Non-paper on the regulatory status of plants generated by oligonucleotide-directed mutagenesis (ODM) 21 May 2015 Obtained through Freedom of

Information request by CEO

BVL Legal interpretation to DG SANTE 28 September 2015 Obtained through Freedom of Information request by CEO

DG SANTE Reply to Vlaams Instituut voor Biotechnologie (VIB) 9 July 2015 Obtained through Freedom of Information request by CEO (doc 24 a2d3)

Vlaams Instituut voor Biotechnologie (VIB) Letter to Mr Ladislav Miko (DG SANTE) 10 June 2015 Obtained through Freedom of Information request by

CEO

DG SANTE Reply to Vlaams Instituut voor Biotechnologie (VIB) 9 July 2015 Obtained through Freedom of Information request by CEO

Vlaams Instituut voor Biotechnologie (VIB) Email to DG SANTE 6 July 2015 Obtained through Freedom of Information request by CEO

VIB Fact series Een schimmelresistente aardappel voor Belgieuml December 2014

50

51

52

53

54

55

56

57

58

59

60

61

62

63

64

65

66

67

68

69

70

71

72

73

74

Food and agriculture

Attached files Attached files

1_briefing_visit_keygenepdf

6pdf

13_presentation_at_esa_-_15-10-2012pdf

14_briefing_visit_nl_dg_2pdf

26_letter_from_fi_registered_versionpdf

30_bto_meeting_with_nbpt-2_registered_versionpdf

34_reply_to_finland_25-4-2014_registered_versionpdf

36_nbt_platform_multilateral_meeting_25_06_2014_steering_note_registered_versionpdf

42_e-mail_dow_agro_to_jrc_-_10-4-2012pdf

431_presentation_cnudde_31-5-2012pdf

44_bto_meeting_31-5-2012pdf

45_proposed_agenda_meeting_22-6-2012pdf

462_ppt_schouten_22-6-2012pdf

51_e-mail_nbt_platform_31-5-2013pdf

511_legal_briefing_paper_-_28-5-2013pdf

512_summary_legal_paper_22-5-2013pdf

513_nbt_factsheetspdf

53_e-mail_from_dow_agro_to_sanco_2-7-2013pdf

54_internal_e-mail_dg_sanco_8-7-2013pdf

561_esa_position_paper_-_fev_2014pdf

57_invitation_to_the_meeting_on_the_future_of_plant_nbts_in_the_eu_25_06_2014pdf

nbt_platform_multilateral_meeting_ares20144089348_-_signed_version_-_third_batchpdf

9pdf

6pdf

12pdf

18pdf

17_20150610_vib_letter_redactedpdf

18_20150615_lettre_autorites_competentes_redactedpdf

21_20150702_reply_to_nbtp-redactedpdf

24_20150709_reply_to_vib_redactedpdf

27_20150722_vib_redactedpdf

28_bto_-_meeting_l_miko_with_new_breeding_technique_platform_-_27_april_2015_redactedpdf

atd_2015-5344_-_doct_2pdf

atd_2015-5344_-_doct_7pdf

atd_2015-5344_-_doct_8pdf

ares20155217184annex-ms_non_paperpdf

httpwwwvibbenleducatieDocumentsVIB_dossier_20schimmelresistent

EASAC Statement on New Breeding Techniques July 2015 httpwwweasaceufileadminPDF_sreports_statementsEasac_14_NBTpdf

EASAC Planting the Future - opportunities and challenges for using crop genetic improvement technologies for sustainable agriculture June 2013

httpwwweasaceufileadminReportsPlanting_the_FutureEASAC_Planting

However one third of the working group are also member of PRRI an industry-minded lobby group of public scientists

Corporate Europe Observatory PRRI - Are these public researchers 2008 httpcorporateeuropeorgfood-and-agriculture200806prri-are-these-p

European Parliament Committee on Agriculture Hearing on ldquoNew Techniques for Plant Breedingrdquo 1 December 2015

httpspolcmssecureeuroparleuropaeucmsdatauploadd35d2641-ab77-49

Furthermore Schuttelaar amp Partners now lists only one client (Grodan a supplier to the horticulture sector) This is in sharp contrast to the lobby firmrsquos

own website where 11 clients from the food and biotech sectors are listed as examples of ldquocurrent and recent clientsrdquo

Schuttelaar amp Partners website As accessed 13 December 2015 httpwwwschuttelaar-partnerscomclients

EU Transparency Register website As accessed 15 November 2015 (No longer in public domain available from CEO)

EU Transparency Register Accessed 16 January 2016

Dorotheacutee Andreacutee DG SANTE Comment at EP Agriculture Committee hearing 1 December 2015

75

76

77

78

79

80

81

0

14_09-28_letter_de_redactedpdf

Tag Tag

genetically modified crops

GMOs

Belgian showfield of DutchGM DuRPhpotatoes

Related Latest

REPORT

Of apples and potatoesthe Dutch lobby for thederegulation ofcisgenesisFEBRUARY 2ND 2016 THE POWER OF

LOBBIES FOOD AND AGRICULTURE

The voice of the Dutch Government has been

loud and clear in Brussels on the issue of

cisgenic plants The Dutch have waged a

sustained campaign to have new GM

techniques ndash and in particular cisgenesis ndash

excluded from EU GMO regulations Several

Dutch ministries the Dutch Parliament the

Dutch Permanent Representation in Brussels

and Dutch MEPs have energetically pursued

this goal

STORY

Canadian company railroads EUdecision-making on new GM

FEBRUARY 2ND 2016 THE POWER OF LOBBIES FOOD AND

AGRICULTURE

At least one developer of new GM crops ndash

Canadian-based Cibus ndash has attempted to

bypass the European policy process by

presenting policy makers with a fait accompli

decisions by individual Member States on the

regulatory status of new techniques as well as

prematurely-launched trials of new GM crops

STORY

EU review of weedkillerglyphosate adds secrecyto controversy

JANUARY 14TH 2016 EFSA FOOD AND AGRICULTURE

More than 80 per cent of the national experts

involved in the EUs official assessment of

glyphosate refused to have their names

disclosed to the public

STORY

Solutions COP21Climate SmartAgriculture boostingthe technofix

DECEMBER 10TH 2015 CLIMATE AND ENERGY FOOD AND

AGRICULTURE

ldquoIf you like greenwashing clap your handsrdquo

1 of 321 of 32 next rsaquo

Corporate Europe Observatory

(CEO) is a research and campaign

group working to expose and

challenge the privileged access

and influence enjoyed by

corporations and their lobby

groups in EU policy making

Read more

CEO relies on grants and

donations to carry out our

research and campaign work By

making a donation or becoming a

friend of CEO you help to

support our efforts to expose

corporate lobbying increase

transparency and urge greater

democratic accountabililty in the

EU

Or

All written content on this

website is licensed under a

Creative Commons Attribution-

NonCommercial-ShareAlike 30

Unported License

Page 12: FOROEUROPA - Biotech lobby’s push for new GMOs to escape … · 2016-02-04 · With respect to cisgenesis and intragenesis, EFSA concluded that while intragenic plants would generate

DG Trade Report from meeting with NBT Platform 07 June 2012 Obtained through Freedom of Information request by CEO

DG Trade Report from meeting with Schuttelaar amp Partners on new breeding techniques 15 March 2012 Obtained through Freedom of Information

request by CEO

European Seed Association (ESA) Position paper Promoting and Enabling Innovation in Plant Breeding February 2014 Obtained through Freedom of

Information request by CEO

NBT Platform Legal Briefing Paper The regulatory status of plants resulting from New Breeding Technologies Version of 28 May 2013 Obtained

through Freedom of Information request by CEO

NBT Platform Summary of Legal Briefing Paper ldquoThe regulatory status of plants resulting fromNew Breeding Technologiesrdquo Obtained through Freedom

of Information request by CEO 22 May 2013 doc 512

The Directive 200118 (Annex 1B) lists two techniques ndash cell fusion and mutagenesis ndash for which an exemption has been granted and that are therefore

excluded from its scope As these two techniques predated the Directive by many years EU authorities assumed there was a lsquohistory of safe usersquo

The following documents exemplify the pro-deregulation arguments Each uses one or more of the points listed in the table

- European Technology Platform Plants for the Future Position paper New Breeding Techniques - Ensuring an Innovative and Diversified European

Agriculture September 2012 httpwwwepsoweborgfile1096

- European Seed Association Regulatory approaches to modern plant breeding - the case of mutagenesis and new gene editing technologies 20 July 2015

httpswwweuroseedseusystemfilespublicationsfilesesa_150543_0pdf

- CropLife International Position Paper Regulatory oversight of products developed through new breeding techniques 2014 httpscroplifeorgwp-

contentuploadspdf_filesRegulatory-Oversight-o

- NBT Platform Factsheet Oligonucleotide-Directed Mutagenesis accelerating innovation 2013 httpwwwnbtplatformorgbackground-

documentsfactsheetsfactsheet-oli

- NBT Platform Legal Briefing Paper The regulatory status of plants resulting from New Breeding Technologies Version of 28 May 2013

- Kraumlmer L Legal questions concerning new methods for changing the genetic conditions in plants Legal analysis commissioned by Arbeitsgemeinschaft

baumluerliche Landwirtschaft (AbL) Bund fuumlr Umwelt und Naturschutz (BUND) etc September 2015

httpwwwtestbiotechorgsitesdefaultfilesKraemer_Legal20questions

- Spranger TM Legal Analysis of the applicability of Directive 200118EC on genome editing technologies Commissioned by the German Federal Agency

for Nature Conservation October 2015 httpbfndefileadminBfNagrogentechnikDokumenteLegal_analysis_of_g

- Cotter J Zimmermann D Van Bekkem H Greenpeace Applications of the EU and Cartagena definitions of a GMO to the classification of plants

developed by cisgenesis and gene-editing techniques 2015 httpwwwgreenpeacetogreenpeacewp-contentuploads201511Applicati

- Reseau Semences Paysannes Confederation Paysanne et al Statut juridique des produits issus des nouvelles techniques de modification geacuteneacutetique des

plantes

DG SANCO Notes from meeting with NBT Platform 21 March 2014 Obtained through Freedom of Information request by CEO

NBT Platform and ETP Plants for the Future Meeting report Multilateral meeting lsquothe future of plant breeding techniques in the European Unionrsquo

Obtained through Freedom of Information request by CEO 25 June 2014

Ibid

Dow Agrosciences and DG SANCOJRC Emails April 2012 and July 2013 Obtained through Freedom of Information request by CEO

DG SANCO Internal email 8 July 2013 Obtained through Freedom of Information request by CEO

Corporate Europe Observatory and Inf OGM TTIP released emails show biotech seeds on the trade talks table 2 July 2015

httpcorporateeuropeorgfood-and-agriculture201507ttip-released-em

European Commission Letter to Competent Authorities 5 June 2015 Obtained through Freedom of Information request by CEO

Cibus Europe Letter to DG SANCO January 2015 Obtained through Freedom of Information request by CEO

Schuttelaar amp Partners Letter to Commissioner Vytenis Andriukaitis 1 December 2014 Obtained through Freedom of Information request by CEO

NBT Platform Email to Mr Ladislav Miko (DG SANTE) 26 February 2015 Obtained through Freedom of Information request by CEO

NBT Platform Email to DG Trade 18 May 2015 Obtained through Freedom of Information request by CEO

According to Agrafacts the non-paper was authored by German UK Irish and Spanish authorities

Non-paper on the regulatory status of plants generated by oligonucleotide-directed mutagenesis (ODM) 21 May 2015 Obtained through Freedom of

Information request by CEO

BVL Legal interpretation to DG SANTE 28 September 2015 Obtained through Freedom of Information request by CEO

DG SANTE Reply to Vlaams Instituut voor Biotechnologie (VIB) 9 July 2015 Obtained through Freedom of Information request by CEO (doc 24 a2d3)

Vlaams Instituut voor Biotechnologie (VIB) Letter to Mr Ladislav Miko (DG SANTE) 10 June 2015 Obtained through Freedom of Information request by

CEO

DG SANTE Reply to Vlaams Instituut voor Biotechnologie (VIB) 9 July 2015 Obtained through Freedom of Information request by CEO

Vlaams Instituut voor Biotechnologie (VIB) Email to DG SANTE 6 July 2015 Obtained through Freedom of Information request by CEO

VIB Fact series Een schimmelresistente aardappel voor Belgieuml December 2014

50

51

52

53

54

55

56

57

58

59

60

61

62

63

64

65

66

67

68

69

70

71

72

73

74

Food and agriculture

Attached files Attached files

1_briefing_visit_keygenepdf

6pdf

13_presentation_at_esa_-_15-10-2012pdf

14_briefing_visit_nl_dg_2pdf

26_letter_from_fi_registered_versionpdf

30_bto_meeting_with_nbpt-2_registered_versionpdf

34_reply_to_finland_25-4-2014_registered_versionpdf

36_nbt_platform_multilateral_meeting_25_06_2014_steering_note_registered_versionpdf

42_e-mail_dow_agro_to_jrc_-_10-4-2012pdf

431_presentation_cnudde_31-5-2012pdf

44_bto_meeting_31-5-2012pdf

45_proposed_agenda_meeting_22-6-2012pdf

462_ppt_schouten_22-6-2012pdf

51_e-mail_nbt_platform_31-5-2013pdf

511_legal_briefing_paper_-_28-5-2013pdf

512_summary_legal_paper_22-5-2013pdf

513_nbt_factsheetspdf

53_e-mail_from_dow_agro_to_sanco_2-7-2013pdf

54_internal_e-mail_dg_sanco_8-7-2013pdf

561_esa_position_paper_-_fev_2014pdf

57_invitation_to_the_meeting_on_the_future_of_plant_nbts_in_the_eu_25_06_2014pdf

nbt_platform_multilateral_meeting_ares20144089348_-_signed_version_-_third_batchpdf

9pdf

6pdf

12pdf

18pdf

17_20150610_vib_letter_redactedpdf

18_20150615_lettre_autorites_competentes_redactedpdf

21_20150702_reply_to_nbtp-redactedpdf

24_20150709_reply_to_vib_redactedpdf

27_20150722_vib_redactedpdf

28_bto_-_meeting_l_miko_with_new_breeding_technique_platform_-_27_april_2015_redactedpdf

atd_2015-5344_-_doct_2pdf

atd_2015-5344_-_doct_7pdf

atd_2015-5344_-_doct_8pdf

ares20155217184annex-ms_non_paperpdf

httpwwwvibbenleducatieDocumentsVIB_dossier_20schimmelresistent

EASAC Statement on New Breeding Techniques July 2015 httpwwweasaceufileadminPDF_sreports_statementsEasac_14_NBTpdf

EASAC Planting the Future - opportunities and challenges for using crop genetic improvement technologies for sustainable agriculture June 2013

httpwwweasaceufileadminReportsPlanting_the_FutureEASAC_Planting

However one third of the working group are also member of PRRI an industry-minded lobby group of public scientists

Corporate Europe Observatory PRRI - Are these public researchers 2008 httpcorporateeuropeorgfood-and-agriculture200806prri-are-these-p

European Parliament Committee on Agriculture Hearing on ldquoNew Techniques for Plant Breedingrdquo 1 December 2015

httpspolcmssecureeuroparleuropaeucmsdatauploadd35d2641-ab77-49

Furthermore Schuttelaar amp Partners now lists only one client (Grodan a supplier to the horticulture sector) This is in sharp contrast to the lobby firmrsquos

own website where 11 clients from the food and biotech sectors are listed as examples of ldquocurrent and recent clientsrdquo

Schuttelaar amp Partners website As accessed 13 December 2015 httpwwwschuttelaar-partnerscomclients

EU Transparency Register website As accessed 15 November 2015 (No longer in public domain available from CEO)

EU Transparency Register Accessed 16 January 2016

Dorotheacutee Andreacutee DG SANTE Comment at EP Agriculture Committee hearing 1 December 2015

75

76

77

78

79

80

81

0

14_09-28_letter_de_redactedpdf

Tag Tag

genetically modified crops

GMOs

Belgian showfield of DutchGM DuRPhpotatoes

Related Latest

REPORT

Of apples and potatoesthe Dutch lobby for thederegulation ofcisgenesisFEBRUARY 2ND 2016 THE POWER OF

LOBBIES FOOD AND AGRICULTURE

The voice of the Dutch Government has been

loud and clear in Brussels on the issue of

cisgenic plants The Dutch have waged a

sustained campaign to have new GM

techniques ndash and in particular cisgenesis ndash

excluded from EU GMO regulations Several

Dutch ministries the Dutch Parliament the

Dutch Permanent Representation in Brussels

and Dutch MEPs have energetically pursued

this goal

STORY

Canadian company railroads EUdecision-making on new GM

FEBRUARY 2ND 2016 THE POWER OF LOBBIES FOOD AND

AGRICULTURE

At least one developer of new GM crops ndash

Canadian-based Cibus ndash has attempted to

bypass the European policy process by

presenting policy makers with a fait accompli

decisions by individual Member States on the

regulatory status of new techniques as well as

prematurely-launched trials of new GM crops

STORY

EU review of weedkillerglyphosate adds secrecyto controversy

JANUARY 14TH 2016 EFSA FOOD AND AGRICULTURE

More than 80 per cent of the national experts

involved in the EUs official assessment of

glyphosate refused to have their names

disclosed to the public

STORY

Solutions COP21Climate SmartAgriculture boostingthe technofix

DECEMBER 10TH 2015 CLIMATE AND ENERGY FOOD AND

AGRICULTURE

ldquoIf you like greenwashing clap your handsrdquo

1 of 321 of 32 next rsaquo

Corporate Europe Observatory

(CEO) is a research and campaign

group working to expose and

challenge the privileged access

and influence enjoyed by

corporations and their lobby

groups in EU policy making

Read more

CEO relies on grants and

donations to carry out our

research and campaign work By

making a donation or becoming a

friend of CEO you help to

support our efforts to expose

corporate lobbying increase

transparency and urge greater

democratic accountabililty in the

EU

Or

All written content on this

website is licensed under a

Creative Commons Attribution-

NonCommercial-ShareAlike 30

Unported License

Page 13: FOROEUROPA - Biotech lobby’s push for new GMOs to escape … · 2016-02-04 · With respect to cisgenesis and intragenesis, EFSA concluded that while intragenic plants would generate

Food and agriculture

Attached files Attached files

1_briefing_visit_keygenepdf

6pdf

13_presentation_at_esa_-_15-10-2012pdf

14_briefing_visit_nl_dg_2pdf

26_letter_from_fi_registered_versionpdf

30_bto_meeting_with_nbpt-2_registered_versionpdf

34_reply_to_finland_25-4-2014_registered_versionpdf

36_nbt_platform_multilateral_meeting_25_06_2014_steering_note_registered_versionpdf

42_e-mail_dow_agro_to_jrc_-_10-4-2012pdf

431_presentation_cnudde_31-5-2012pdf

44_bto_meeting_31-5-2012pdf

45_proposed_agenda_meeting_22-6-2012pdf

462_ppt_schouten_22-6-2012pdf

51_e-mail_nbt_platform_31-5-2013pdf

511_legal_briefing_paper_-_28-5-2013pdf

512_summary_legal_paper_22-5-2013pdf

513_nbt_factsheetspdf

53_e-mail_from_dow_agro_to_sanco_2-7-2013pdf

54_internal_e-mail_dg_sanco_8-7-2013pdf

561_esa_position_paper_-_fev_2014pdf

57_invitation_to_the_meeting_on_the_future_of_plant_nbts_in_the_eu_25_06_2014pdf

nbt_platform_multilateral_meeting_ares20144089348_-_signed_version_-_third_batchpdf

9pdf

6pdf

12pdf

18pdf

17_20150610_vib_letter_redactedpdf

18_20150615_lettre_autorites_competentes_redactedpdf

21_20150702_reply_to_nbtp-redactedpdf

24_20150709_reply_to_vib_redactedpdf

27_20150722_vib_redactedpdf

28_bto_-_meeting_l_miko_with_new_breeding_technique_platform_-_27_april_2015_redactedpdf

atd_2015-5344_-_doct_2pdf

atd_2015-5344_-_doct_7pdf

atd_2015-5344_-_doct_8pdf

ares20155217184annex-ms_non_paperpdf

httpwwwvibbenleducatieDocumentsVIB_dossier_20schimmelresistent

EASAC Statement on New Breeding Techniques July 2015 httpwwweasaceufileadminPDF_sreports_statementsEasac_14_NBTpdf

EASAC Planting the Future - opportunities and challenges for using crop genetic improvement technologies for sustainable agriculture June 2013

httpwwweasaceufileadminReportsPlanting_the_FutureEASAC_Planting

However one third of the working group are also member of PRRI an industry-minded lobby group of public scientists

Corporate Europe Observatory PRRI - Are these public researchers 2008 httpcorporateeuropeorgfood-and-agriculture200806prri-are-these-p

European Parliament Committee on Agriculture Hearing on ldquoNew Techniques for Plant Breedingrdquo 1 December 2015

httpspolcmssecureeuroparleuropaeucmsdatauploadd35d2641-ab77-49

Furthermore Schuttelaar amp Partners now lists only one client (Grodan a supplier to the horticulture sector) This is in sharp contrast to the lobby firmrsquos

own website where 11 clients from the food and biotech sectors are listed as examples of ldquocurrent and recent clientsrdquo

Schuttelaar amp Partners website As accessed 13 December 2015 httpwwwschuttelaar-partnerscomclients

EU Transparency Register website As accessed 15 November 2015 (No longer in public domain available from CEO)

EU Transparency Register Accessed 16 January 2016

Dorotheacutee Andreacutee DG SANTE Comment at EP Agriculture Committee hearing 1 December 2015

75

76

77

78

79

80

81

0

14_09-28_letter_de_redactedpdf

Tag Tag

genetically modified crops

GMOs

Belgian showfield of DutchGM DuRPhpotatoes

Related Latest

REPORT

Of apples and potatoesthe Dutch lobby for thederegulation ofcisgenesisFEBRUARY 2ND 2016 THE POWER OF

LOBBIES FOOD AND AGRICULTURE

The voice of the Dutch Government has been

loud and clear in Brussels on the issue of

cisgenic plants The Dutch have waged a

sustained campaign to have new GM

techniques ndash and in particular cisgenesis ndash

excluded from EU GMO regulations Several

Dutch ministries the Dutch Parliament the

Dutch Permanent Representation in Brussels

and Dutch MEPs have energetically pursued

this goal

STORY

Canadian company railroads EUdecision-making on new GM

FEBRUARY 2ND 2016 THE POWER OF LOBBIES FOOD AND

AGRICULTURE

At least one developer of new GM crops ndash

Canadian-based Cibus ndash has attempted to

bypass the European policy process by

presenting policy makers with a fait accompli

decisions by individual Member States on the

regulatory status of new techniques as well as

prematurely-launched trials of new GM crops

STORY

EU review of weedkillerglyphosate adds secrecyto controversy

JANUARY 14TH 2016 EFSA FOOD AND AGRICULTURE

More than 80 per cent of the national experts

involved in the EUs official assessment of

glyphosate refused to have their names

disclosed to the public

STORY

Solutions COP21Climate SmartAgriculture boostingthe technofix

DECEMBER 10TH 2015 CLIMATE AND ENERGY FOOD AND

AGRICULTURE

ldquoIf you like greenwashing clap your handsrdquo

1 of 321 of 32 next rsaquo

Corporate Europe Observatory

(CEO) is a research and campaign

group working to expose and

challenge the privileged access

and influence enjoyed by

corporations and their lobby

groups in EU policy making

Read more

CEO relies on grants and

donations to carry out our

research and campaign work By

making a donation or becoming a

friend of CEO you help to

support our efforts to expose

corporate lobbying increase

transparency and urge greater

democratic accountabililty in the

EU

Or

All written content on this

website is licensed under a

Creative Commons Attribution-

NonCommercial-ShareAlike 30

Unported License

Page 14: FOROEUROPA - Biotech lobby’s push for new GMOs to escape … · 2016-02-04 · With respect to cisgenesis and intragenesis, EFSA concluded that while intragenic plants would generate

0

14_09-28_letter_de_redactedpdf

Tag Tag

genetically modified crops

GMOs

Belgian showfield of DutchGM DuRPhpotatoes

Related Latest

REPORT

Of apples and potatoesthe Dutch lobby for thederegulation ofcisgenesisFEBRUARY 2ND 2016 THE POWER OF

LOBBIES FOOD AND AGRICULTURE

The voice of the Dutch Government has been

loud and clear in Brussels on the issue of

cisgenic plants The Dutch have waged a

sustained campaign to have new GM

techniques ndash and in particular cisgenesis ndash

excluded from EU GMO regulations Several

Dutch ministries the Dutch Parliament the

Dutch Permanent Representation in Brussels

and Dutch MEPs have energetically pursued

this goal

STORY

Canadian company railroads EUdecision-making on new GM

FEBRUARY 2ND 2016 THE POWER OF LOBBIES FOOD AND

AGRICULTURE

At least one developer of new GM crops ndash

Canadian-based Cibus ndash has attempted to

bypass the European policy process by

presenting policy makers with a fait accompli

decisions by individual Member States on the

regulatory status of new techniques as well as

prematurely-launched trials of new GM crops

STORY

EU review of weedkillerglyphosate adds secrecyto controversy

JANUARY 14TH 2016 EFSA FOOD AND AGRICULTURE

More than 80 per cent of the national experts

involved in the EUs official assessment of

glyphosate refused to have their names

disclosed to the public

STORY

Solutions COP21Climate SmartAgriculture boostingthe technofix

DECEMBER 10TH 2015 CLIMATE AND ENERGY FOOD AND

AGRICULTURE

ldquoIf you like greenwashing clap your handsrdquo

1 of 321 of 32 next rsaquo

Corporate Europe Observatory

(CEO) is a research and campaign

group working to expose and

challenge the privileged access

and influence enjoyed by

corporations and their lobby

groups in EU policy making

Read more

CEO relies on grants and

donations to carry out our

research and campaign work By

making a donation or becoming a

friend of CEO you help to

support our efforts to expose

corporate lobbying increase

transparency and urge greater

democratic accountabililty in the

EU

Or

All written content on this

website is licensed under a

Creative Commons Attribution-

NonCommercial-ShareAlike 30

Unported License

Page 15: FOROEUROPA - Biotech lobby’s push for new GMOs to escape … · 2016-02-04 · With respect to cisgenesis and intragenesis, EFSA concluded that while intragenic plants would generate

STORY

Solutions COP21Climate SmartAgriculture boostingthe technofix

DECEMBER 10TH 2015 CLIMATE AND ENERGY FOOD AND

AGRICULTURE

ldquoIf you like greenwashing clap your handsrdquo

1 of 321 of 32 next rsaquo

Corporate Europe Observatory

(CEO) is a research and campaign

group working to expose and

challenge the privileged access

and influence enjoyed by

corporations and their lobby

groups in EU policy making

Read more

CEO relies on grants and

donations to carry out our

research and campaign work By

making a donation or becoming a

friend of CEO you help to

support our efforts to expose

corporate lobbying increase

transparency and urge greater

democratic accountabililty in the

EU

Or

All written content on this

website is licensed under a

Creative Commons Attribution-

NonCommercial-ShareAlike 30

Unported License